FDA/USDA August RECALLS &AMP; UPDATES FOR PREVIOUS MONTHS ~ SAFETY ALERTS~ 2021

** 028-2021, Serenade Foods Recalls Frozen Raw Breaded Stuffed Chicken Products due to Possible Salmonella Enteritidis Contamination (Aug 10, 2021)

** Fratelli Beretta USA, Inc., a Mount Olive, N.J. establishment, is recalling approximately 862,000 pounds of uncured antipasto products that may be contaminated with Salmonella Infantis and/or Salmonella Typhimurium, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The ready-to-eat (RTE) uncured antipasto meat trays were produced on February 28, 2021 through August 15, 2021. The following products are subject to recall [view labels]:

24-oz. trays containing two 12-oz packages of “Fratelli Beretta UNCURED ANTIPASTO PROSCIUTTO, SOPPRESSATA, MILANO SALAMI & COPPA” with best by dates of AUG 27 21 through FEB 11 22 and UPC code 073541305316.

The products subject to recall bear establishment number “EST. 7543B” printed on the packaging next to the best by date. These items were shipped to retail locations nationwide. Consumers with questions regarding the recall can contact Fratelli Beretta USA Inc.’s recall hotline at 1-866-918-8738. Media may contact Marco Lastrico of Barabino & Partners USA, at m.lastrico@barabinousa.com or 917-634-1685.

** Willow Tree Poultry Farm, an Attleboro, Mass. establishment, is recalling approximately 52,022 pounds of various chicken salads and dip products that may be contaminated with extraneous materials, specifically hard white plastic the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The ready-to-eat (RTE) various chicken salads and dip items were produced on August 10, 2021 through August 13, 2021. The following products are subject to recall:

5-lb container of “Willow Tree Premium White Meat Caesar Chicken Dip” with sell by dates of 09/03/2021 and 09/06/2021.
5-lb and 12-oz containers of “Willow Tree Premium White Meat Buffalo Chicken Dip” with sell by dates of 09/03/2021 and 09/05/2021.
5-lb container of “Willow Tree Premium White Meat Buffalo Chicken Salad” with a sell by date of 09/07/2021.
15-oz container of “Willow Tree Premium White Meat Buffalo Chicken Salad” with sell by dates of 09/07/2021 and 09/09/2021.
15-oz container of “Willow Tree Premium White Meat Cranberry Walnut Chicken Salad” with a sell by date of 09/08/2021.
15-oz container of “Willow Tree Premium White Meat Classic Chicken Salad” with sell by dates of 09/07/2021, 09/08/2021, 09/09/2021, 09/10/2021.
7.5-oz container of “Willow Tree Premium White Meat Classic Chicken Salad” with sell by dates of 09/07/2021 and 09/09/2021.
10-lb container of “Willow Tree Premium White Meat Classic Chicken Salad” with a sell by date of 09/08/2021.

The products subject to recall bear establishment number “EST. P-8827” inside the USDA mark of inspection. These items have been shipped to wholesale and retail locations in Connecticut, Massachusetts, Maine, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, and Vermont.

** Avanti Frozen Foods Pvt. Ltd, is voluntarily expanding a prior recall issued on June 25,2021 to include certain consignments of various sizes of frozen cooked, peeled, deveined, shrimp (with some packaged with cocktail sauce) sold in various unit sizes, because it has the potential to be contaminated with Salmonella. The frozen shrimp products were distributed nationwide from November 2020 to May 2021.

This recall expansion has been initiated out of an abundance of precaution and will cover a large amount of product that has not been associated with any illness but been undertaken following discussions with FDA and CDC and reflects Avanti’s commitment to Public health and safety.

Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The affected product details in the expansion are as below

Product Description	Unit Size	Container Description	Storage Instructions	Code	Expiration Date
BIG RIVER, Frozen Cooked Peeled and Deveined Tail Off Shrimps IQF	2 LB	Printed Polythene Pouch	Frozen	10.02.2022, 10.03.2022, 10.05.2022	10/02/2022, 10/03/2022, 10/05/2022
365, Frozen Cooked Peeled and Deveined Tail On Shrimps IQF	2 LB	Printed Polythene Pouch	Frozen	91AS/18HN/201D, 91AS/19HN/202A, 91AS/28YN/272A, 91AS/30YN/274	04/18/2022, 04/19/2022, 06/28/2022, 06/30/2022
AHOLD, Frozen Cooked Peeled and Deveined Tail On Shrimps IQF	1 LB	Printed Polythene Pouch	Frozen	AQ-23-2950-1, AQ-23-2960-1, AQ-23-3380-1, AQ-23-3390-1, AQ-23-3520-1, AQ-23-3530-1	10/21/2022, 10/22/2022, 12/03/2022, 12/04/2022, 12/17/2022, 12/18/2022
AHOLD, Frozen Cooked Peeled and Deveined Tail On Shrimps IQF	2 LB	Printed Polythene Pouch	Frozen	AQ-23-2930-1, AQ-23-2940-1, AQ-23-3180-1, AQ-23-3200-1, AQ-23-3450-1, AQ-23-3470-1	10/19/2022, 10/20/2022, 11/13/2022, 11/15/2022, 12/10/2022, 12/12/2022
CENSEA, Frozen Cooked Peeled and Deveined Tail Off Shrimps IQF	2 LB	Printed Polythene Pouch	Frozen	140323D, 140324D, 140325D, 140326D, 140329D, 140330D, 140331D, 140332D	11/18/2022, 11/19/2022, 11/20/2022, 11/21/2022, 11/24/2022, 11/25/2022, 11/26/2022, 11/27/2022
COS, Frozen Cooked Peeled and Deveined Tail On Shrimps IQF with Cocktail Sauce	16 OZ.	Printed Polythene Pouch	Frozen	91AS/12HN/195C, 91AS/13HN/196A, 91AS/26YN/270C, 91AS/27YN/271B	10/11/2022, 10/12/2022, 12/25/2022, 12/26/2022
CWNO BRAND, Frozen Cooked Peeled and Deveined Tail On Shrimps IQF	7 LB	Printed Polythene Pouch	Frozen	91AS/08YN/252D, 91AS/10YN/254A, 91AS/13YN/257D, 91AS/14YN/258C, 91AS/21YN/265A, 91AS/22YN/266A	03/08/2022, 03/10/2022, 03/13/2022, 03/14/2022, 03/21/2022, 03/22/2022
FIRST STREET, Frozen Cooked Peeled and Deveined Tail On Shrimps IQF	2 LB	Printed Polythene Pouch	Frozen	1879-03291, 1879-03301	11/23/2022, 11/24/2022
Nature’s Promise, Frozen Cooked Peeled and Deveined Tail On Shrimps IQF	12 OZ.	Printed Polythene Pouch	Frozen	EF AVF 0061 1	07/05/2022
HARBOR BANKS, Frozen Cooked Peeled and Deveined Tail On Shrimps IQF	2 LB	Printed Polythene Pouch	Frozen	02572 0328 10, 02572 0353 10, 02572 0358 10	11/23/2022, 12/18/2022, 12/23/2022
HARBOR BANKS, Frozen Cooked Peeled and Deveined Tail Off Shrimps IQF	2 LB	Printed Polythene Pouch	Frozen	02572 0329 10	11/24/2022
HOS, Frozen Cooked Peeled and Deveined Tail On Shrimps IQF	2 LB	Printed Polythene Pouch	Frozen	46002310, 49002310, 58002310, 61002310	10/16/2022, 10/17/2022
HOS, Frozen Cooked Peeled and Deveined Tail Off Shrimps IQF	2 LB	Printed Polythene Pouch	Frozen	61002300, 70002300	10/17/2022
MEIJER, Frozen Cooked Peeled and Deveined Tail On Shrimps IQF	1 LB	Printed Polythene Pouch	Frozen	28520 49485, 28620 49485, 32320 50738, 32420 50738, 33420 50739, 33520 50739	10/10/2022, 10/11/2022, 11/17/2022, 11/18/2022, 11/28/2022, 11/29/2022
MEIJER, Frozen Cooked Peeled and Deveined Tail On Shrimps IQF with Cocktail Sauce	10 OZ.	Printed Polythene Pouch	Frozen	91AS/09HN/192C, 91AS/10HN/193A, 91AS/21HN/204D, 91AS/13YN/257B, 91AS/31YN/275B	10/08/2022, 10/09/2022, 10/20/2022, 12/12/2022, 12/30/2022
MEIJER, Frozen Cooked Peeled and Deveined Tail On Shrimps IQF with Cocktail Sauce	16 OZ.	Printed Polythene Pouch	Frozen	91AS/22HN/205B, 91AS/14YN/258, 91AS/01TP/276A	10/21/2022, 12/13/2022, 12/31/2022
MEIJER, Frozen Cooked Peeled and Deveined Tail On Shrimps IQF with Cocktail Sauce	20 OZ.	Printed Polythene Pouch	Frozen	91AS/22HN/205B, 91AS/14YN/258, 91AS/01TP/276A	10/21/2022, 12/13/2022, 12/31/2022
COS,Frozen Cooked Peeled and Deveined Tail Off Shrimps IQF	2 LB	Printed Polythene Pouch	Frozen	91AS/07TP/282B	01/06/2023
SANDBAR, Frozen Cooked Peeled and Deveined Tail On Shrimps IQF	2 LB	Printed Polythene Pouch	Frozen	AVF 29220 EF, AVF 29320 EF, 91AS/11YN/255B, 91AS/14YN/258D, 91AS/28YN/272B, 91AS/29YN/273A, 91AS/31YN/275C, 91AS/01TP/276C, 91AS/12TP/287C, 91AS/13TP/288A	10/17/2022, 10/18/2022, 12/10/2022, 12/13/2022, 12/27/2022, 12/28/2022, 12/30/2022, 12/31/2022, 01/11/2023, 01/12/2023
SEA COVE, Frozen Cooked Peeled and Deveined Tail Off Shrimps IQF	2 LB	Printed Polythene Pouch	Frozen	27296-20-316, 27296-20-317	11/10/2022, 11/11/2022
SEA COVE, Frozen Cooked Peeled and Deveined Tail Off Shrimps IQF	1 LB	Printed Polythene Pouch	Frozen	27296-20-318, 27296-20-320	11/12/2022, 11/14/2022
WATERFRONT BISTRO, Frozen Cooked Peeled and Deveined Tail On Shrimps IQF with Cocktail Sauce	16 OZ.	Polythene Trays	Frozen	20277, 20278, 20282, 20283, 20294, 20295, 20342, 20344, 20346, 20347, 20357, 20358, 20365, 21003, 21005, 21006, 21007, 21008, 21009, 21010, 21011, 21013	10/02/2022, 10/03/2022, 10/07/2022, 10/08/2022, 10/19/2022, 10/20/2022, 12/06/2022, 12/08/2022, 12/10/2022, 12/11/2022, 12/21/2022, 12/22/2022, 12/29/2022, 01/02/2023, 01/04/2023, 01/05/2023, 01/06/2023, 01/07/2023, 01/08/2023, 01/09/2023, 01/10/2023, 01/12/2023
WELLSLEYFARMS, Frozen Cooked Peeled and Deveined Tail On Shrimps IQF with Cocktail Sauce	40 OZ.	Polythene Trays	Frozen	91AS/01HN/184A, 91AS/04HN/187E	09/30/2023, 10/03/2022
WFNOBRANDS, Frozen Cooked Peeled and Deveined Tail On Shrimps IQF with Cocktail Sauce	40 OZ.	Polythene Trays	Frozen	91AS/31YN/275, 91AS/01TP/276	06/30/2022, 07/01/2023
HANNAFORD,Frozen Cooked Peeled and Deveined Tail On Shrimps IQF	1 LB	Printed Polythene Pouch	Frozen	AVF 00721 EF, AVF 00821 EF, AVF 00921 EF	12/28/2022, 12/29/2022, 12/30/2022
FOODLION,Frozen Cooked Peeled and Deveined Tail On Shrimps IQF	1 LB	Printed Polythene Pouch	Frozen	AVF 00821 EF, AVF 00921 EF, AVF 01021 EF	12/29/2022, 12/30/2022, 12/31/2022

Products not bearing these codes are not affected by or involved in this recall. There have been 9 reports of Salmonella-related illness to date associated with these cooked shrimp distributions. The company has taken several preventive steps and initiatives to eliminate potential for future contaminations.

Consumers who have purchased the above product are urged not to consume the recalled product and to return them to the place of purchase. Consumers with questions may contact the company at +914023310260/+914023310261, Mon – Fri :10:00 am – 5:00 PM , GMT+5.5.

Outbreak Investigation of Salmonella Weltevreden: Shrimp (April 2021)

** 8/14/2021, Mai Cuisine Inc., of Allentown, PA is voluntarily recalling 67 packs of 12pc Shrimp Tempura Kabuki Roll WR purchased in the state of California only in relation to the Shrimp recall expansion initiated by Avanti Frozen Foods Pvt. Ltd, due to potential salmonella contamination in frozen shrimp

The products are packed in clear lid containers, with labels indicating the product name, ingredients and best by date. The products can be identified with the Hand-Crafted date of 8/12/2021 and 8/13/2021 and Best By Date of 08/13/2021 and 08/14/2021 and the following UPCs:

12pc Shrimp Tempura Kabuki Roll WR UPC 8 4003140626 2.

Products were sold from Mai Sushi counters inside Target stores in northern California at the following locations:

Store Name	Address
T2767 Oakland-Emeryville	1555 40th Street, Emeryville, CA 94608
T2829 Alameda	2700 Fifth Street, Alameda, CA 94501
T3201 San Francisco CBD East	225 Bush St, San Francisco, CA 94104
T2766 San Francisco Central	789 Mission St, San Francisco, CA 94103
T3267 Berkeley Univ Ave	1414 University Ave, Berkeley, CA 94702
T3202 Berkeley Central	2187 Shattuck Ave, Berkeley, CA 94704
T3240 Marin City	180 Donahue St, Sausalito, CA 94965
T3297 SF Folsom and 13th St	1690 Folsom St, San Francisco, CA 94103
T3330 Oakland Broadway & 27th	2650 Broadway, Oakland, CA 94612
T3353 Daly City Westlake	100 Westlake Center, Daly City, CA 94015
T1926 Albany	1057 Eastshore Hwy, Albany, CA 94710
T1122 San Mateo Fashion Island	2220 Bridgepointe Pkwy, San Mateo, CA 94404
T1054 Tanforan	1150 El Camino Real, San Bruno, CA 94066
T1407 Daly City Serramonte	133 Serramonte Ctr, Daly City, CA 94015
T0320 Colma	5001 Junipero Serra Blvd, Colma, CA 94014
T3264 San Francisco Stonestown	233 Winston Dr, San Francisco, CA 94132

No illnesses have been reported to date.

The recall was initiated after Avanti Frozen Foods Pvt. Ltd expanded their recall to a particular Lot of frozen shrimp received by Mai Sushi at some of our California locations. Although these products have shelf life of 1 day, the firm is initiating this recall to ensure customer safety.

This recall is being made with the knowledge of the U.S. Food and Drug Administration.

All affected Mai Cuisine Inc., products are intended for customers to consume immediately upon purchase and have a shelf life of 1 day. However, out of abundance of caution, to ensure the safety of our customers, Mai Cuisine Inc., has initiated this voluntary recall. Consumers who have purchased this item from Mai Sushi Counters in the above mentioned stores are urged to dispose the product and contact (484) 223-4502 External Link Disclaimer for a full refund.

** Houston, Texas, eBay Seller ID: jongu 4308 is voluntarily recalling all lots of Hydro Pineapple Burn to consumer level. FDA analysis has found the product to contain undeclared sibutramine. Sibutramine was an FDA approved drug used as an appetite suppressant for weight loss but was withdrawn from the market because of safety issues. The presence of sibutramine in Hydro Pineapple Burn renders it an unapproved drug for which safety and efficacy has not been established and therefore subject to recall. To date, jongu 4308 has not receive any report of adverse events related to this recall

Risk Statement: product containing sibutramine pose a health risk to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

This tainted product is marketed as a dietary supplement for weigh losst and is packaged in a box containing ten 20g sachets. Hydro Pineapple Burn was distributed by eBay via internet at www.ebay.com External Link Disclaimer nationwide in the USA (from 05/29/2021 to 07/27/2021). On August 03, 2021, FDA issued a press release that warned consumers to avoid certain products found eBay, Amazon, and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms.

eBay Seller ID: jongu 4308 is notifying its customers by this press announcement and via e-mail of this recall. Consumers that have Hydro Pineapple Burn, which is being recalled should stop using and destroy them. Consumers with questions regarding this recall can contact eBay Seller ID: jongu 4308 by messaging on eBbay or email: johnnyvn100@yahoo.com. Consumers should contact their physicians or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

** 8/14/2021, Mai Franchising Inc., of Allentown, PA is voluntarily recalling 103 packs of sushi containing cocktail shrimp for products purchased in the state of California only.in relation to the Shrimp recall expansion initiated by Avanti Frozen Foods Pvt. Ltd, due to potential salmonella contamination in frozen shrimp.

Name	UPC
SPICY SHRIMP TEMPURA ROLL	81282401109
SPECIAL ROLL SUPER SET 16PC	81282401129
CHEF’S ASSORTED NIGIRI 6PC	81282401130
SCORPION ROLL	81282401138
BR SPECIAL ROLL SUPER SET 16PC	81282401203
COOKED VARIETY PACK	81282401349
SHRIMP MANGO FRESH ROLL	81282401374

Products were sold from Mai Sushi counters inside New Leaf Community Market stores in northern California at the following locations:

Store Name	Address
New Leaf Market – Capitola	1210 41st Avenue, Capitola, CA 95010
New Leaf Market – Evergreen	5667 Silver Creek Valley Road, San Jose, CA 95138
New Leaf Market – Halfmoon Bay	150 San Metro Road, half Moon Bay, CA 94019
New Leaf Market – Pacific	1134 Pacific Avenue, Santa Cruz, CA 95060
New Leaf Market – Santa Cruz	1101 Fair Avenue, Santa Cruz, CA 95060

This recall is being made with the knowledge of the U.S. Food and Drug Administration

All affected Mai Franchising LLC., products are intended for customers to consume immediately upon purchase and have a shelf life of 1 day. However, out of abundance of caution, to ensure the safety of our customers, Mai Franchising LLC., has initiated this voluntary recall. Consumers who have purchased these items from Mai Sushi Counters in the above mentioned stores are urged to dispose the product and contact (484) 223-4502 External Link Disclaimer for a full refund.

** Hostess Brands, LLC (“Hostess Brands”) is voluntarily recalling certain Hostess® Soft White Hamburger Buns and Soft White Hot Dog Buns due to the potential for the products to be contaminated with Listeria monocytogenes and Salmonella. Hostess Brands is recalling the impacted products out of an abundance of caution after becoming aware of this issue from its co-manufacturer, Best Harvest Bakeries, through Best Harvest Bakeries’ environmental monitoring program. To date, Hostess Brands has received no reports of illness related to this issu

Listeria monocytogenes is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

Salmonella is an organism that can cause serious and sometimes fatal infections in young children, elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses.

This recall is limited to the following Hostess® Soft White Hamburger Buns and Soft White Hot Dog Buns, which were sold to distributors, convenience stores, and other retail stores throughout the United States:

Product	Item UPC	Batch	Best By Date
Hostess® Soft White Hamburger Buns	888109110987	I060989300 I061189300 I061289300 I061489300 I061389300 I061589300 I061689300 I061789300 I061889300 I061989300 I062089300 I062489300 I062589300 I062989300 I070389300 I070289300 I063089300 I070789300 I070689300 I070889300 I070989300 I071089300 I071389300 I071189300 I071489300 I071289300 I071589300 I071689300 I072089300 I072389300 I072989300 I073189300	8/13/2021 8/15/2021 8/16/2021 8/18/2021 8/17/2021 8/19/2021 8/20/2021 8/21/2021 8/22/2021 8/23/2021 8/24/2021 8/28/2021 8/29/2021 9/2/2021 9/6/2021 9/5/2021 9/3/2021 9/10/2021 9/9/2021 9/11/2021 9/12/2021 9/13/2021 9/16/2021 9/14/2021 9/17/2021 9/15/2021 9/18/2021 9/19/2021 9/23/2021 9/26/2021 10/2/2021 10/4/2021
Hostess® Soft White Hot Dog Buns	888109110970	I060989300 I062189300 I062289300 I062389300 I062589300 I062689300 I063089300 I070189300 I070689300 I071289300 I072089300 I072189300 I072289300 I072389300 I072489300 I072789300	8/13/2021 8/25/2021 8/26/2021 8/27/2021 8/29/2021 8/30/2021 9/3/2021 9/4/2021 9/9/2021 9/15/2021 9/23/2021 9/24/2021 9/25/2021 9/26/2021 9/27/2021 9/30/2021

As Best Harvest Bakeries only manufactures certain Hostess® hamburger buns and hot dog buns for Hostess Brands, no other Hostess® products are affected, including Hostess® bread and bagel products.

Consumers who have purchased an affected product are urged to immediately dispose of the product or return it to the place of purchase for a full refund.

Consumers with questions may contact 1-800-483-7253 and also visit www.hostesscakes.com External Link Disclaimer.

** Hanford, California, Je Dois L’avoir Boutique is voluntarily recalling all of the 365 Skinny High Intensity Pills and or 365 Skinny Emergency Boutique, 30 day capsules supply to the retail/consumer level. The 365 Skinny High Intensity Pills and 365 Skinny Emergency Boutique have been found to contain Sibutramine which is a controlled substance by the DEA and poses significant health risks to consumers both products are from the same manufacturer 365 Skinny is the strongest form and the 365 Skinny Emergency is for people with high blood pressure, diabetes but not limited to other chronic illnesses.

Risk Statement: The 365 Skinny High Intensity Pills and 365 Skinny Emergency Boutique potentially can cause serious health risks such as seizures, tachycardia, palpitations, heart attacks and allergic reactions. Risks associated with this product are more likely with people who have high blood pressure, thyroid disease, men or woman over 65 or children under 16 years old. Je Dois L’avoir Boutique has not received any reports of adverse events related to this recall.

The product is used together with diet and exercise to assist with weight loss and is packaged in bottles of 30 capsules 600mg per capsule.

All lots and expiration dates of any of these products are being recalled. Je Dois L’avoir is recalling ALL 365 Skinny High Intensity Pills and 365 Emergency Boutique that it has sold to the public as seen below.

Je Dois L’avoir is notifying its distributors and customers by email and is arranging for return/replacement etc. of all recalled products. Consumers that have 365 High Intensity Skinny or 365 Skinny Emergency Boutique which is being recalled should stop using/return to place of purchase/discard/contact Je Dois L’avoir Boutique Immediately at 559-302-6215.

Consumers with questions regarding this recall can contact Je Dois L’avoir Boutique by phone Monday-Friday 9-6pm pacific standard time or email us at jedois2020@gmail.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

** Pfizer is voluntarily recalling an additional four lots of Chantix 0.5mg/1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily Intake (ADI) level.

Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication. The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.

Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time. ⁱ

Chantix is a treatment to help patients quit smoking and is intended for short term use. People who smoke cigarettes are 15 to 30 times more likely to get lung cancer than people who do not smoke. ⁱⁱ Smoking is also associated with many other cancers.ⁱⁱⁱ CHANTIX has a safety profile that has been established over 15 years of marketing authorization and through a robust clinical program. Pfizer believes the benefit/risk profile of CHANTIX remains positive. Patients currently taking Chantix should consult with their doctor to confirm if they received an affected lot, and if appropriate, about alternative treatment options. To date, Pfizer has not received any reports of adverse events that have been related to this recall.

The NDC, Lot Number, Expiration Date, and Configuration details for Chantix Tablets is indicated in the table below with the four additional lots. Photos of the products can be found at the end of this press release. The product lots were distributed nationwide to wholesalers and Distributors in the United States and Puerto Rico from June 2019 to June 2021.

Product	NDC	Lot Number	Expiration Date	Presentation	Configuration/Count
Chantix (varenicline) Tablets, 0.5 mg	0069-0468-56	00019213	2022 JAN	Bottles	56 tablets/bottle
Chantix (varenicline) Tablets, 0.5 mg	0069-0468-56	EC6994	2023 MAY	Bottles	56 tablets/bottle
Chantix (varenicline) Tablets, 1 mg	0069-0469-56	EA6080	2023 MAR	Bottles	56 tablets/bottle
Chantix (varenicline) Tablets, 1 mg	0069-0469-56	EC9843	2023 MAR	Bottles	56 tablets/bottle
Chantix (varenicline) Tablets, 0.5/1 mg	0069-0471-03	00018522	2021 AUG	Cartons containing 2 blister packs	Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg tablets
Chantix (varenicline) Tablets, 0.5/1 mg	0069-0471-03	00018523	2021 AUG	Cartons containing 2 blister packs	Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg tablets
Chantix (varenicline) Tablets, 0.5/1 mg	0069-0471-03	00018739	2021 AUG	Cartons containing 2 blister packs	Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg tablets
Chantix (varenicline) Tablets, 0.5/1 mg	0069-0471-03	00018740	2021 AUG	Cartons containing 2 blister packs	Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg tablets
Chantix (varenicline) Tablets, 0.5/1 mg	0069-0471-03	00020231	2021 SEP	Cartons containing 2 blister packs	Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg tablets
Chantix (varenicline) Tablets, 0.5/1 mg	0069-0471-03	00020232	2021 NOV	Cartons containing 2 blister packs	Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg tablets
Chantix (varenicline) Tablets, 0.5/1 mg	0069-0471-03	00020357	2021 DEC	Cartons containing 2 blister packs	Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg tablets
Chantix (varenicline) Tablets, 0.5/1 mg	0069-0471-03	00020358	2022 JAN	Cartons containing 2 blister packs	Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg tablets
Chantix (varenicline) Tablets, 0.5/1 mg	0069-0471-03	00020716	2022 JAN	Cartons containing 2 blister packs	Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg tablets
Chantix (varenicline) Tablets, 0.5/1 mg	0069-0471-03	ET1600	01/2023	Cartons containing 2 blister packs	Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg tablets
Chantix (varenicline) Tablets, 0.5/1 mg	0069-0471-03	ET1607	01/2023	Cartons containing 2 blister packs	Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg tablets
Chantix (varenicline) Tablets, 0.5/1 mg	0069-0471-03	ET1609	01/2023	Cartons containing 2 blister packs	Carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42 1 mg tablets

Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified their direct consignees by letter to arrange for return of any recalled product.

Wholesalers and distributors with an existing inventory of the lots, listed in the table above, should stop use and distribution and quarantine the product immediately.

If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you. Please conduct a sub-recall to those accounts and communicate this recall information immediately. Please request they immediately cease distribution of the affected product and promptly contact Stericycle at 888-276-6166 (Mon.-Fri. 8:00 am – 5:00 pm ET) to obtain a Business Reply Card (BRC) to initiate the return process.

If you received free product through the Pfizer Patient Assistance Program (PAP) or the Pfizer Institutional Patient Assistance Program (IPAP), please check your stock immediately against the table above. If you have any of the affected product lots in your inventory, please follow the instructions above for returning the product to Stericycle Inc. Additionally, if you are aware of any patients to whom you dispensed the affected lots who still may have the product in their possession, please ask them to return the product to you and then follow the instructions above for returning the product to Stericycle Inc. To request replacement product for any Pfizer PAP or Pfizer IPAP product you return, please contact 833-203-2776 (Mon.-Fri. 8:00 am – 6:00 pm ET).

As communicated by FDA, there is no immediate risk to patients taking Chantix. ^iv Patients who are taking this product should consult with their health care provider or pharmacy to determine if they have the affected product lots. Patients with the affected lots should contact Stericycle Inc. at 888-276-6166 (Mon.-Fri. 8:00 am – 5:00 pm ET) for instructions on how to return their product and obtain reimbursement for their cost.

Healthcare Professionals with questions regarding this recall can contact Pfizer using the below information.

Contact Center	Contact Information	Area of Support
Pfizer Medical Information	800-438-1985, option 3 (Mon.-Fri. 9 am-5 pm ET) www.pfizermedinfo.com External Link Disclaimer	For medical questions regarding the product
Pfizer Drug Safety	800-438-1985, option 1 (24 hours a day; 7 days a week)	To report adverse events and product complaints

Adverse events or product complaints experienced with the use of this product may also be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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