Tag Archives: Hospira

~ FDA/USDA ~~ Alerts & Safety

FDA Alerts & Recalls


11/01/2013 02:12 PM EDT
The recent expansion of the Reser’s Fine Foods product recall for potential Listeria monocytogenes contamination has impacted select prepared foods offerings sold at Giant Eagle, Inc. locations in Pennsylvania, Ohio, Maryland and West Virginia. As a result, Giant Eagle has implemented a voluntary recall of Diced Summer Slaw, Diced Summer Salad and several Grab and Go combo meals that may include Diced Summer Slaw.

 

 

The Perrigo Company announced that it has initiated a voluntary, nationwide product recall to the retail level of 18 batches of its acetaminophen infant suspension liquid, 160 mg/5 mL, sold in 2 oz. and 4 oz. bottles with syringes in a box under store brand products including Babies R Us, Care One and more  (refer to the Firm Press Release for full list of affected brand names and products).

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English: Logo of the . (Photo credit: Wikipedia)
10/31/2013 06:36 PM EDT: On September 16, 2013 PENTAX Medical Company initiated a voluntary nationwide recall of 76 PENTAX Gas/ Water Valves, model OF-B194. The valves were offered as a separate purchase for use with PENTAX GI Video Endoscopes (90i/90k series and i10/k10 series).
10/31/2013 09:11 PM EDT
World Class Distribution of Fontana, California is voluntarily recalling one specific lot of Trader Joes Southwest Salad (SKU 56077) with a Use by Date11/2/13, because it may not list soy in the ingredients. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products. No illnesses have been reported to date.

Updated information Maryland Firm Recalls Broccoli Salad Kits for Possible Listeria Contamination (Oct 25, 2013) / Maryland and Texas Firms Recall Broccoli Salad Products with Dressing for Possible Listeria Contamination (Oct 29, 2013).

 10/26/2013 08:47 AM EDT
Kraft Foods Group is voluntarily recalling some varieties of Kraft and Polly-O String Cheese and String Cheese Twists products. These products may spoil before their “Best When Used By” code dates, leading to product discoloration.
10/26/2013 09:29 PM EDT
Reser’s Fine Foods of Beaverton, Oregon is voluntarily expanding its October 22, 2013 recall of refrigerated ready-to-eat products because they may be contaminated with Listeria monocytogenes. Listeria is an organism which can cause serious and sometime fatal infections in young children, frail or elderly people and individuals with weakened immune systems
10/07/2013 08:35 AM EDT
Orange County Produce, LLC (“OC Produce”) is voluntarily working with the Food and Drug Administration (“FDA”) and California Department of Public Health (“CDPH”) to coordinate a recall of fresh red and green Bell Peppers for potential contamination with Salmonella. The FDA has advised that a random sample of OC Produce Bell peppers has tested positive for Salmonella.
10/01/2013 05:45 PM EDT
Mandy Star Trading Inc., located at 349 Maujer Street Brooklyn NY 11206 is recalling “Good Taste” brand Plum, because it contains undeclared sulfites and unallowed E124 (Acid Red 18) dye. People who have a severe sensitivity to sulfites run the risk of serious or life-threatening allergic-like reactions if they consume this product.
10/04/2013 07:42 PM EDT
Atossa Genetics Inc. (NASDAQ: ATOS) initiated a voluntary recall to remove the ForeCYTE Breast Health Test and the Mammary Aspiration Specimen Cytology Test (MASCT) device from the market. This voluntary recall includes the MASCT System Kit and Patient Sample Kit.
10/04/2013 07:39 PM EDT
Hospira, Inc.(NYSE: HSP), announced today it has initiated a voluntary nationwide recall of one lot of 1% Lidocaine HCI Injection, USP, 10 mg/mL, 20 mL Multiple-dose Fliptop Vial, NDC 0409-4276-01 Lot 25-090-DK (the lot number may be followed by 01 or 02).
10/03/2013 08:21 PM EDT
OnTime Distribution Inc. of Brooklyn, NY, is voluntarily recalling PRAN brand Spice Powder TURMERIC because it was found to contain high levels of lead that could cause health problems to consumers, particularly infants, small children, and pregnant women if consumed. Recent analysis of the product found that it contained lead levels as high as 28 and 42 parts per million (ppm).
10/04/2013 05:29 PM EDT
On August 27, 2013, H&H Medical Corporation initiated a nationwide recall of 6,619 units of the H&H Emergency Cricothyrotomy Kit. The product has been found to show the potential for a defective cuff balloon on the provided endotracheal airway.
10/08/2013 10:37 AM EDT
Today Dräger issued a statement regarding its voluntary recall on specific Fabius anesthesia machines. Dräger initiated this voluntary action in August of 2013 as a result of an internal investigation into devices that did not pass the high voltage test portion of the final production test.
10/15/2013 08:55 AM EDT
Yoder’s Country Market, is recalling custom gift boxes distributed in December 2012 because they may contain 11 oz. bags of honey roasted peanuts which contain undeclared milk and wheat. People who have allergies to milk or wheat run the risk of serious or life-threatening allergic reaction if they consume the honey roasted peanuts. No other components of the gift boxes are affected.
10/11/2013 04:36 PM EDT
Barrel O’ Fun Snack Foods Co. of Perham, MN is recalling one specific lot of Safeway Snack Artist BBQ Potato Chips (UPC 21130-29106) because they contain undeclared milk. People with an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reactions if they consume this product.
10/07/2013 02:34 PM EDT
Turkey Hill Dairy of Conestoga, Pa., is recalling specific packages of 1.5 qt. (48 oz./1.42L) of Fudge Ripple Premium Ice Cream and 1 Pint (16 oz./473 ml) packages of Chocolate Peanut Butter Cup Premium Ice Cream, and Moose Tracks Stuff’d Frozen Dairy Dessert due to the possibility that some packages may contain metal shavings.
10/15/2013 04:39 PM EDT
B. Braun Medical Inc. (B.Braun) is voluntarily recalling one lot of 1g Cefepime for Injection USP and Dextrose Injection USP (Lot H3A744, catalog 3193-11) to the consumer level. The 1g Cefepime for Injection USP and Dextrose Injection USP lot has been found to contain visible organic particulate matter in a reserve sample unit
10/02/2013 10:25 AM EDT
Hospira, Inc. (NYSE: HSP), announced today it initiated a voluntary nationwide recall of one lot of Metoclopramide Injection, USP, 10 mg/2 mL (5 mg/mL), NDC 0409-3414-01, Lot 28-104-DK and two lots of Ondansetron Injection, USP, 4 mg/2 mL, (2 mg/mL), NDC 0409-4755-03, Lots 29-484-DK and 29-510-DK. This action is due to a confirmed vial defect where glass particulate matter (glass strands) were identified as being affixed to the inside of the vial walls. There is potential for the glass particulates to dislodge into the solution.
10/09/2013 03:09 PM EDT
B@B Trade, Inc., Florida is voluntarily recalling all lots of Slim Fortune, Lidiy, and Slim Expert to the consumer level. The FDA laboratory analysis of these dietary supplements found to contain undeclared Sibutramine.
10/08/2013 03:54 PM EDT
Asia Cash & Carry Inc. of Maspeth, New York is voluntarily recalling PRAN brand Spice Powder TURMERIC, Net Wt. 8.82 oz. (250 gm) jars, because it was found to contain high levels of lead that could cause health problems to consumers, particularly infants, small children, and pregnant women if consumed. Recent analysis of the product found it contained 28 parts per million (ppm).
10/16/2013 09:13 AM EDT
BEST VALUE, INC. of Detroit, MI is voluntarily recalling PRAN TURMERIC POWDER because it was found to contain high levels of lead that could cause health problems to consumers, particularly infants, small children, and pregnant women if consumed. The recall was initiated after it was discovered that product contained high levels of lead (53 ppm) based on sampling by Food and Drug Administration.
10/16/2013 03:51 PM EDT
GE Healthcare has initiated a voluntary field corrective action for the Engström ventilator and Aespire View, Aisys, and Avance anesthesia machines due to a potential safety issue. The affected units were manufactured between the dates of April 23, 2013 and July 22, 2013.
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U.S. Food & Drug Administration (FDA) ~~ October 2013


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Recent Food Recalls

 

Turkey Hill Dairy Issues Voluntary Recall of Chocolate Peanut Butter Cup Premium Ice Cream,
Fudge Ripple Premium Ice Cream, and Moose Tracks Stuff’d Frozen Dairy Dessert

Recall due to possible foreign matter; limited to select stores in Pennsylvania, Maryland and West Virginia

 

 

Haute Health, LLC Conducts Voluntary Nationwide Recall of All Lots Of Virilis Pro, PHUK And Prolifta Capsules Due To Undeclared Ingredients

09/30/2013 05:36 PM EDT
Haute Health, LLC is voluntarily recalling all lots of Virilis Pro, PHUK and Prolifta at the retail and consumer level. Virilis Pro, PHUK and Prolifta have been found to contain amounts of the PDE-5 Inhibitor sildenafil, which is an active ingredient in an FDA-approved drug for erectile dysfunction (ED).

Big Blue Fisheries, Llc Recalls All Smoked Products From All Lots, Various Sizes, in Vacuum Packaging Because of Possible Health Risk

09/30/2013 09:33 PM EDT
Big Blue Fisheries is recalling ALL smoked products from all lots and codes, various sizes, in vacuum packages because the products may not have been properly cooked and have the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.
Carefusion Provides Update On Voluntary Recall Of Avea® Ventilator

09/30/2013 08:08 PM EDT
CareFusion issued the following update regarding its previously announced voluntary recall of AVEA® ventilators. The company initiated the voluntary recall on Sept. 3, 2013
Afikim Electric Vehicles Issues Nationwide Recall of Breeze C Scooter

09/30/2013 05:18 PM EDT
On September 27, 2013, Afikim Electric Vehicles initiated a nationwide recall of 69 Breeze C Scooters. The Breeze C Scooter may become unresponsive during operation due to an electrical contact which may fault due to extensive wear, which potentially could result in the driver not being able to stop the scooter during operation except by turning off the ignition key.
~ FDA/USDA ~~ Alerts & Safety

U.S. Food & Drug Administration (FDA) ~~ September 2013


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English: Logo of the . (Photo credit: Wikipedia)
09/25/2013 10:20 AM EDT
W.S. Badger Co. Inc. today announced it is voluntarily recalling all lots of its 4-ounce SPF 30 Baby Sunscreen Lotion and one lot of its 4-ounce SPF 30 Kids Sunscreen Lotion
09/24/2013 03:17 PM EDT
Garden-Fresh Foods is initiating an expansion to our voluntary recall on various ready-to-eat salads, slaw, and dip products sold under various brands and code dates (see attachment). The products may be contaminated with Listeria monocytogenes, an organism that can cause serious and sometimes-fatal infections in young children, frail or elderly people, and others with weakened immune systems.
09/19/2013 01:39 PM EDT
A limited number of P.F. Chang’s Home Menu Pork and Leek Dumpling frozen appetizer sold at retail in 12.5 ounce bags is being recalled due to the possible presence of undeclared allergens, crustacean shellfish (shrimp) and fish (pollock). There have been no reported cases of illness. This recall does not affect any P.F. Chang’s restaurants.
09/19/2013 07:09 PM EDT
Baxter International Inc. announced today it has initiated a voluntary recall of two lots of its Dual Luer Lock Caps (Product Code 2C6250, Lots 10043 and 10044) because of the presence of loose particulate matter found in the packaging. Particulate matter entering the fluid path from the Luer Lock Caps may result in thrombotic and embolic events, including: pulmonary embolism, myocardial infarction and stroke.
09/20/2013 02:26 PM EDT
Semifreddi’s Inc. of Alameda, CA is recalling all packaged Almond Biscotti and Chocolate Dipped Almond Biscotti because the food allergens milk and soy were not declared on the product labels. People who have an allergy or severe sensitivity to milk or soy run the risk of serious allergic reaction, including anaphylaxis, if they consume the products.
09/16/2013 03:28 PM EDT
HeartSine Technologies, Ltd. initiated a voluntary global correction of certain Samaritan® 300/300P PAD public access defibrillators to address two separate issues that may affect the ability to deliver therapy to a patient in a sudden cardiac arrest (SCA) event, if needed.
09/19/2013 04:25 PM EDT
Wegmans is recalling 4,327 units of Wegmans brand APPLE CINNAMON Mini Muffins, Net Wt. 14 oz., because the product contains undeclared soy. People who have an allergy to soy run the risk of serious or life-threatening allergic reaction if they consume this product.
09/13/2013 07:11 PM EDT
Myerstown, PA – September 12, 2013 – As a result of an internal review, Dutch Valley is issuing a recall on Honey Roasted Peanuts due to undeclared Milk and Wheat Ingredients. Individuals with food allergies to Milk and or Wheat may run the risk of a serious or life threatening allergic reaction if they consume these products.
09/13/2013 06:52 PM EDT
Hospira, Inc. (NYSE: HSP), announced today, on July 12, 2013, it initiated a voluntary nationwide recall to the user level for one lot of 0.25% Bupivacaine HCl Injection, USP (2.5 mg/mL), 30 mL Single-dose Vial (NDC 0409-1159-02). An expanded recall was issued on August 29, 2013 for one lot of 0.75% Bupivacaine HCl Injection, USP (7.5 mg/mL), 30 mL Single-dose Vial (NDC 0409-1165-02).
09/12/2013 05:51 PM EDT
Schwebel Baking Company today recalled 18,979 units of Golden Rich Buns with Honey due to mislabeling and undeclared egg. Through the package validation process the problem was discovered.
09/11/2013 03:44 PM EDT
Leiter’s Compou
09/13/2013 10:56 AM EDT
Ge Pharma, LLC of North Haven, CT is recalling Creafuse Powder Grape Lot# GE4568 and Creafuse Powder Fruit Punch Lot #GE4570, packaged in a white, 600 gram container with an expiration date of 2/2015 because it contains 1,3 dimethylamylamine (DMAA). DMAA is commonly used as a stimulant, pre-workout, and weight loss ingredient in dietary supplement products.

nding Pharmacy is voluntarily recalling 3 lots of its sterile products due to concerns of sterility assurance with Front Range Laboratories, Leiter’s Compounding Pharmacy’s independent testing laboratory. The use of a non-sterile injectable product exposes patients to the risk of contracting serious life-threatening infections.

09/11/2013 03:52 PM EDT
Talenti® Gelato & Sorbetto is voluntarily initiating a product recall of Talenti German Chocolate Cake Gelato pints with the UPC # 1 8685200063 1 with a BEST BY DATE of 11/04/2014 M1, 11/24/2014 M1, and 11/24/2014 M2 as a precautionary measure. The recall was initiated after it was discovered by the firm that the product may contain undeclared almonds.
09/10/2013 07:23 PM EDT
Bubbles Baking Co. is voluntarily recalling 9,229 cases of Blueberry Muffin 14 oz and Blueberry Loaf Cake 16 oz. due to undeclared milk and soy allergen. People who have allergies to milk and soy run the risk of serious or life-threatening reactions if they consume these products
09/09/2013 03:07 PM EDT
Avella Specialty Pharmacy is voluntarily recalling two compounded sterile medications. The recall is a result of concerns of sterility assurance with the specialty pharmacy‘s independent testing laboratory, Front Range Laboratories.
09/10/2013 01:54 PM EDT
Park Compounding is voluntarily recalling one lot of sterile medication Testoserone Cypionate (Sesame Oil) 200mg/ml Lot #05072013@1 Exp: 11/3/2013 for injection in 10ml amber vials, to the consumer level.
09/09/2013 03:16 PM EDT
General Mills announced today a voluntary Class II recall of a limited quantity of refrigerated Pillsbury Cinnamon Rolls with Icing. No other flavors or varieties of Pillsbury Cinnamon Rolls or Pillsbury dough products are being recalled.
09/06/2013 05:49 PM EDT
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. (“McNeil”) is voluntarily recalling at the retail level three lots, approximately 200,000 bottles, of Concentrated MOTRIN® Infants’ Drops Original Berry Flavor 1/2 fl oz bottles distributed in the United States (see full product list below). This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).
09/05/2013 11:51 AM EDT
Chobani, Inc., of Twin Falls, Idaho is voluntarily recalling Greek Yogurt. The company has ceased the distribution of the product due to reports of product bloating and swelling and some claims of illness as the company continues its investigation to identify the root cause.
09/06/2013 05:07 PM EDT
GoPicnic Brands, Inc. is voluntarily recalling two vegan ready-­‐to-­‐ eat meals, GoPicnic Black Bean Dip & Plantain Chips and Hummus & Crackers, containing Professor Zim Zam’s Extraordinary Sweets Dark Chocolate with Orange and Dark Chocolate with Sea Salt. The chocolate products in these meals may contain an undeclared milk allergen.
09/06/2013 07:18 PM EDT
University Compounding Pharmacy is voluntarily recalling the following preparations (see below) for injection, to the consumer level. In a recent inspection, FDA investigators observed that methods used by the Independent Third Party laboratory to assess sterility may have resulted in pharmacies receiving inaccurate laboratory test results. FDA has concerns that results obtained from
09/06/2013 10:01 PM EDT
Aqueboque, NY, Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling a total of nine (9) lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 30 mL, to the consumer level. There have been no reports of adverse effects to consumers so
09/05/2013 03:04 PM EDT
Medaus Pharmacy is voluntarily recalling certain sterile compounded consumer products (see table) due to our inability to confirm that the quality control testing performed on these specific lots by an independent, third party laboratory was conducted in a manner consistent with the highest standards of excellence we demand from ourselves and on behalf of our patients. Though Medaus received test results indicating that these lots met all safety standards, they are being recalled because the independent testing lab’s sterility testing practices as applied to these lots indicate that the product’s sterility cannot be confirmed
09/05/2013 05:01 PM EDT
Cains Foods is recalling 2,273 six-pack cases of 16 oz. Olde Cape Cod Chipotle Ranch dressing with a “Best By” date of Nov. 30, 2014 because it may contain undeclared milk and egg. People who have allergies to milk and egg run the risk of serious or life-threatening reactions if they consume products containing these ingredients.
08/30/2013 06:22 PM EDT
Garden-Fresh Foods, Inc. of Milwaukee Wisconsin is recalling A Limited Quantity of Spartan Fresh Selections American Potato Salad In 16 oz. Packages, because it has the potential to be contaminated with Listeria monocytogenes, an organism which 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.
08/30/2013 08:24 PM EDT
Hospira, Inc. announced today it is initiating a voluntary nationwide user-level recall of one lot of Aminosyn II 10 percent, Sulfite-Free, 500mL, NDC 0409-4164-03 Lot 26-138-JT. This action is due to one confirmed customer report where an unknown foreign particle was included in the injection port and in contact with product. The foreign particle was confirmed by Hospira as human hair. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. This recall is being conducted as a precautionary measure.
08/30/2013 08:37 PM EDT
Premier Foods, LLC of Santa Fe Springs, CA is voluntarily recalling four flavored sauces due to the failure to declare the following allergens on the product labels: milk, soy, and/or wheat. The products were sold at Williams-Sonoma. People who have allergies to milk, soy, and/or wheat run the risk of serious or life-threatening reactions if they consume products containing these ingredients.
08/30/2013 04:31 PM EDT
St. Louis, Missouri, Nestle Purina PetCare Company (NPPC) is voluntarily recalling a limited number of 3.5-pound bags of its Purina ONE beyOnd Our White Meat Chicken and Whole Barley Recipe Adult Dry Dog Food from a single production run and shipped to retail customers in the United States. This is being done because one bag of the product was found to be contaminated with Salmonella.
~ FDA/USDA ~~ Alerts & Safety

U.S. Food & Drug Administration (FDA)


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05/17/2013 09:41 AM EDT
Rural King Distributing of Mattoon, IL is recalling 205 tons of Deer Corn, because it has the potential to be contaminated with aflatoxin. Aflatoxin is a naturally occurring mold by-product.
 
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05/10/2013 04:49 PM EDT
Hannaford Supermarkets is recalling two products sold in the bakery section because they may contain nuts that are not listed on the product packaging label. Individuals who have an allergy or severe sensitivity to any nuts may run the risk of serious or life-threatening allergic reaction should they consume these items.
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05/10/2013 04:00 PM EDT
The Compounding Shop, LLC is conducting a voluntary recall of all lots of sterile products compounded by the pharmacy that are not expired. The recall is being initiated due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
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05/10/2013 04:53 PM EDT
Queen Creek, AZ, BeaMonstar Products is voluntarily recalling all of SexVoltz brand SKU’s 626570609490, 827912089028, 626570617877, 626570615316, 626570615316 Velextra brand SKU’s 626570613855, 626570619055, 626570617860, 626570617563 Amerect SKU’s 626570619031, 626570619628 capsules to the consumer level. Laboratory analysis conducted by the FDA on SexVoltz and Velextra has determined these products contain undeclared tadalafil. Amerect is voluntarily recalled because it has the potential to contain undeclared tadalafil. Tadalafil are FDA-Approved drugs used to treat male erectile dysfunction (ED), making the products unapproved new drugs.
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05/10/2013 10:09 PM EDT
May 10, 2013 – Weston, Florida: Apotex Corp. announced today that it is conducting, on behalf of the manufacturer Hospira, Inc., a voluntary nationwide recall of 21 lots of Piperacillin and Tazobactam for Injection, USP 40.5 grams, NDC number 60505-0773-00 to the hospital / healthcare provider /user level. The impacted lots of Piperacillin and Tazobactam for Injection, USP 40.5 grams may show precipitation / crystallization in IV bag or IV line after reconstitution.
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05/10/2013 04:48 PM EDT
Smart & Final of Los Angeles, Calif., which previously announced a recall of certain production dates of 2.5 lb – La Romanella Tri-Color Cheese Tortellini, is expanding its recall to include additional production dates due to undeclared wheat, eggs and milk. People who have an allergy or severe sensitivity to wheat, eggs and/or milk run the risk of serious or life-threatening allergic reaction if they consume these products.
 
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04/29/2013 04:13 PM EDT
WESTON, FL, April 26, 2013 /CNW/ – Apotex Corp. announced today that it is conducting, on behalf of the manufacturer Hospira, Inc., a voluntary nationwide recall of 15 lots of Piperacillin and Tazobactam for Injection, USP 40.5 grams, NDC number 60505-0773-00 to the hospital / healthcare provider /user level. The impacted lots of Piperacillin and Tazobactam for Injection, USP 40.5 grams may show precipitation / crystallization in IV bag or IV line after reconstitution.
 
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04/29/2013 03:46 PM EDT
Smart & Final of Los Angeles, Calif. is recalling 2.5 lb. La Romanella Tri-Color Cheese Tortellini because it may contain undeclared wheat, eggs and milk. People who have an allergy or severe sensitivity to wheat, eggs and /or milk run the risk of serious or life-threatening allergic reaction if they consume these products.
 
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04/29/2013 02:26 PM EDT
Maple View Farm is voluntarily recalling pint containers of Cookies & Cream, Carolina Crunch and Cookie Dough ice cream because the products contain allergens that were not declared on package labels. Some or all of the products contain wheat,soy, almonds and peanuts, which can cause serious allergic reactions in people who have an allergy or sensitivity to these ingredients.
 
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04/27/2013 03:07 PM EDT
Today, ConAgra Foods, Inc., (NYSE: CAG) in cooperation with the U.S. Food and Drug Administration (FDA) is voluntarily recalling packages of its Orville Redenbacher’s Classic Kettle Korn flavor ready-to-eat popcorn that may contain an undeclared allergen, milk. Certain bags of the Kettle Korn flavored ready-to-eat popcorn may have inadvertently been filled with white cheddar flavored popcorn, which contains an allergen, milk.
 
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04/26/2013 08:22 AM EDT
Hospira, Inc. (NYSE: HSP), announced today that last August it initiated a voluntary nationwide user-level recall of one lot of 0.9% Sodium Chloride Injection, USP, 100 mL, Flexible Container, NDC 0409-7984-23. This action was due to one confirmed customer report where four separate particulate issues were identified in four individual flexible containers.