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08/30/2017 05:20 PM EDTLucky Mart Inc. is voluntarily recalling lots C14005, C16001 and C16002 of Piyanping Anti-Itch Lotion to the consumer level. The product was manufactured using the active pharmaceutical ingredient dexamethasone rather than hydrocortisone. Dexamethasone is not listed as an ingredient in the labeling.
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08/30/2017 06:53 PM EDTMid Valley Pharmaceutical is recalling lot# 23221701 of Doctor Manzanilla Cough & Cold and lot# 23221701 of Doctor Manzanilla Allergy & Decongestant Relief syrup to the consumer level. The products may potentially be contaminated with the bacteria Burkholderia cepacia. Contaminated products with Burkholderia cepacia can potentially result in serious infections, may be life-threating in patients with compromised immune systems. To date, Mid Valley Pharmaceutical, LLC has not received any reports of adverse events related to this recall.
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08/30/2017 10:05 PM EDTHospira, Inc., a Pfizer company, is voluntarily recalling one lot of Vancomycin Hydrochloride for Injection, USP, 750 mg/vial (NDC 0409-6531-02) lot 632153A, to the hospital/retailer level. The recall was due to a confirmed customer report for the presence of particulate matter, confirmed as glass, within a single vial.
- USDA Integrates Recalls Information into ‘FoodKeeper’ Application The U.S. Department of Agriculture (USDA) today announced new updates to its popular FoodKeeper application that will provide users with new information on food safety recalls. The app has been updated so users can choose to receive automatic notifications when food safety recalls are announced by USDA’s Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA).
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Piyanping Anti-Itch Lotion: Recall – Incorrect Active Ingredient
AUDIENCE: Consumer, Pharmacy
ISSUE: Lucky Mart Inc. is voluntarily recalling lots C14005, C16001 and C16002 of Piyanping Anti-Itch Lotion to the consumer level. The product was manufactured using the active pharmaceutical ingredient dexamethasone rather than hydrocortisone. Dexamethasone is not listed as an ingredient in the labeling.
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Doctor Manzanilla Cough & Cold and Doctor Manzanilla Allergy & Decongestant Relief Syrup: Recall – Potential Contamination with Burkholderia cepacia
AUDIENCE: Consumers, Pharmacy
ISSUE: Mid Valley Pharmaceutical is recalling lot# 23221701 of Doctor Manzanilla Cough & Cold and lot# 23221701 of Doctor Manzanilla Allergy & Decongestant Relief syrup to the consumer level. The products may potentially be contaminated with the bacteria Burkholderia cepacia. Contaminated products with Burkholderia cepacia can potentially result in serious infections, may be life-threating in patients with compromised immune systems. To date, Mid Valley Pharmaceutical, LLC has not received any reports of adverse events related to this recall.
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08/30/2017 03:40 PM EDTDemakes Enterprises, Inc., a Lynn, Mass. establishment, is recalling approximately 32,228 pounds of fully cooked chicken sausage product due to misbranding and undeclared allergens
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08/24/2017 08:58 PM EDTCook Medical initiated a correction to the Instructions For Use (IFU) for the Zenith Alpha™ Thoracic Endovascular Graft. This correction removed the indication for blunt thoracic aortic injury, also known as BTAI or “transection” of the aorta because Cook has received an increase in reports of graft thrombosis and occlusion with these grafts specifically in the treatment of BTAI. Cook also initiated a voluntary recall of Zenith Alpha Thoracic products in sizes of 18-22mm, including the 26-22mm tapered device. These specific sizes are primarily used for BTAI, and are no longer available for purchase.
- Blossom Foods, LLC Recalls Frozen Meat Products Due to Misbranding and Undeclared Allergens Blossom Foods, LLC, an Oakland, Calif. establishment, is recalling approximately 15,092 pounds of beef, chicken and pork products due to misbranding and undeclared allergens
- Ronald A. Chisholm, Ltd. Recalls Pork Belly Products Produced Without Benefit of Import Inspection Ronald A. Chisholm, Ltd., a Toronto, Ontario establishment, is recalling approximately 12,169 pounds of skinless pork belly products that were not presented at the U.S. point of entry for inspection
- Diluigi Foods Inc. Recalls Chicken Sausage Products Due to Misbranding and Undeclared Allergens DiLuigi Foods Inc., a Danvers, Mass. establishment, is recalling approximately 3,448 pounds of chicken breakfast sausage products due to misbranding and undeclared allergens.
- Updated information is now available. A list of retail consignees has been posted for recall 094-2017, Fair Oaks Farms, LLC Recalls Pork Sausage Patties Due to Possible Listeria Contamination (Aug 22, 2017).
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Ninjacof and Ninjacof A: Recall – Potential Burkholderia Cepacia Contamination
08/23/2017 10:52 AM EDTCenturion Labs is voluntarily recalling, as a precautionary measure, 1 lot of Ninjacof (Lot# 200N1601) and 1 lot of Ninjacof A (Lot# 201NA1601) manufactured by Vilvet (Dania Beach, FL) and distributed by Centurion Labs to the retail level due to potential contamination with Burkholderia cepacia. Centurion was notified by the FDA regarding the potential contamination as they discovered this product may have been manufactured in a Pharmatech, FDA registered facility, in Davie, FL. that was found to have a product that contained B. cepacia. -
08/23/2017 04:08 PM EDTOut of an abundance of caution, SunOpta Inc’s subsidiary, Sunrise Growers Inc., has issued a voluntary recall of certain frozen organic dark sweet pitted cherry products due to 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.
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08/23/2017 10:52 AM EDTCenturion Labs is voluntarily recalling, as a precautionary measure, 1 lot of Ninjacof (Lot# 200N1601) and 1 lot of Ninjacof A (Lot# 201NA1601) manufactured by Vilvet (Dania Beach, FL) and distributed by Centurion Labs to the retail level due to potential contamination with Burkholderia cepacia. Centurion was notified by the FDA regarding the potential contamination as they discovered this product may have been manufactured in a Pharmatech, FDA registered facility, in Davie, FL. that was found to have a product that contained B. cepacia.
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08/23/2017 07:15 PM EDTExpresco Foods, Inc., a Montréal, Québec establishment, is recalling approximately 20,446 pounds of imported chicken skewer products that may be adulterated with Listeria monocytogenes
- Fair Oaks Farms, LLC Recalls Pork Sausage Patties Due to Possible Listeria Contamination Fair Oaks Farms, LLC, a Pleasant Prairie, Wis. establishment, is recalling approximately 1,134 pounds of pork sausage patties that may be adulterated with Listeria monocytogenes.
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08/17/2017 12:53 PM EDTUnited Trading Inc of Des Plaines, IL, is recalling its 7 ounce and 14 ounce packages of “Gazab Green Raisins (Chinese)”, because it may contain undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products.
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USDA Secretary Sonny Perdue and USTR Robert Lighthizer Announce Expanded Access for U.S. Rice Exports to Colombia (WASHINGTON, D.C., Aug. 17, 2017) – U.S. Department of Agriculture Secretary Sonny Perdue and the U.S. Trade Representative Robert Lighthizer today announced an agreement reached with the government of Colombia to allow for expanded market access for U.S. exports of paddy rice.
- (Aug. 17, 2017) – The U.S. Department of Agriculture (USDA) announced today that the government of South Korea has lifted its ban on imports of U.S. poultry and poultry products, including fresh eggs. Korea had imposed the ban in response to a recent detection of highly pathogenic avian influenza (HPAI).for more info go to USDA website
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Zenith Alpha Thoracic Endovascular Graft by Cook Medical: Class I Recall – Potential Formation of Thrombus Inside Device
AUDIENCE: Risk Manager, Cardiology, Surgery, Patient ISSUE: Cook Medical Inc. is recalling the Zenith Alpha Thoracic Endovascular Graft when used for the treatment of Blunt Traumatic Aortic Injury (BTAI) because blood clots (thrombus) may form inside the device after implantation. Cook Medical is also aware of reported cases where the graft became blocked or closed (occlusion) when used to treat BTAI. Thrombosis or occlusion may lead to serious adverse health consequences, including death.
- Missa Bay, LLC Recalls Chicken Products Due To Misbranding and an Undeclared Allergen
Missa Bay, LLC, a Swedesboro, N.J. establishment, is recalling approximately 1,719 pounds of chicken caesar salad products due to misbranding and an undeclared allergen - Luvo Inc. (USA) Recalls Poultry Products Due To Misbranding and Undeclared Allergens
Luvo Inc. (USA), a Blaine, Washington establishment, is recalling approximately 4,805 pounds of poultry products due to misbranding and undeclared allergens. - . Updated information is now available. A list of retail consignees has been posted for recall 091-2017, Kenosha Beef International, LTD. Recalls Beef Products Due To Misbranding and Undeclared Allergens (Aug 9, 2017).
- Updated information is now available. A list of retail consignees has been posted for recall 082-2017, Marathon Enterprises Inc. Recalls Hot Dog Products Due to Possible Extranous Material Contamination (Jul 15, 2017)
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08/10/2017 03:22 PM EDTInternational Laboratories, LLC is voluntarily recalling one (1) Lot of Pravastatin Sodium Tablets USP 40 mg packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as Pravastatin Sodium Tablets USP 40 mg but contained Bupropion Hydrochloride XL 300 mg tablets.
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08/10/2017 03:36 PM EDTAs a precautionary measure, the distribution firms Leader Brand, Major Pharmaceuticals, and Rugby Laboratories are jointly issuing a nationwide voluntary recall of all lots within expiry of all liquid products manufactured by PharmaTech LLC at its FDA registered facility in Davie, Fla. due to possible product contamination.
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