Animal & Veterinary Recalls
In Association with Pet Brands Products, LLC, ALDI Voluntarily Recalls Pet Advent Calendars Due to Potential Choking Hazard
Batavia, Ill. (December 9, 2021) – In cooperation with Pet Brands Products, LLC, and out of an abundance of caution, ALDI is voluntarily recalling Pure Being Cat Advent Calendars and Pure Being Dog Advent Calendars as a precautionary measure due to a potential choking hazard.
After receiving a small number of customer complaints and discussion with the supplier, ALDI immediately removed the affected products from stores.
Drug Recalls
Mylan Pharmaceuticals Inc., a Viatris Company, Conducting Voluntary Recall of One Batch of Semglee® (insulin glargine injection), 100 units/mL (U-100), 3 mL Prefilled Pens, Due to the Potential for a Missing Label in the Batch
PITTSBURGH – Jan. 18, 2022 – Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of its non-interchangeable Semglee® (insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens, which are packaged in a labelled carton of five (5) pens. The product is being recalled due to the potential for the label to be missing on some prefilled pens within a labelled carton for this particular batch.
This batch was manufactured by Biocon Sdn Bhd. and distributed by Mylan Specialty L.P. in the U.S. between May 11, 2021 and November 11, 2021.
Lohxa LLC Issues Voluntary Nationwide Recall of Senna Syrup 8.8mg/5mL Due to Microbial Contamination
FOR IMMEDIATE RELEASE – 01/11/2022 – Worcester, MA. Lohxa LLC is voluntarily recalling one lot of Senna Syrup 8.8mg/5mL, unit-dose cups to the consumer level. The product is being recalled due to microbial contamination.
Use of contaminated product by the elderly, patients with a weakened immune system, or patients at a higher risk of developing life-threatening inflammation of the heart, could result in infections that could be life-threatening. To date, Lohxa LLC has not received any reports of adverse events related to this recall.
The product is used as a natural vegetable laxative for the relief of occasional constipation and is packaged into 5 mL unit-dose cups. The product is distributed into cases of 20 cartons packaged with 24 units each, NDC: 50268-731-24. The affected Senna Syrup 8.8mg/5mL lot is AM1115S with expiration date of 01/2023. The product can be identified by the label below. Product was distributed to AvKare (Wholesaler) who may have further distributed this to clinics, hospitals, and healthcare providers.
Viona Pharmaceuticals Inc., Issues Voluntary Nationwide Recall of Metformin HCl Extended- Release Tablets, USP 750 mg, Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity
FOR IMMEDIATE RELEASE – 01/07/2022 – Cranford, New Jersey, Viona Pharmaceuticals Inc., is voluntarily recalling twenty-three (23) lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg at the consumer level. The reason for the recall is an Out of Specification (OOS) result observed for one lot of the product (M008132) “N-nitrosodimethylamine (NDMA) (By GC- MS/MS)” test at 17 Month(s), 25°C/60%RH Long-term stability samples. In an abundance of caution, the firm has decided to voluntarily recall 23 batches which we have determined having a valid shelf life within the US market. This product was manufactured by Cadila Healthcare Limited, Ahmedabad, India for U.S. distribution by Viona Pharmaceuticals Inc.
Food & Beverage Recalls
Frozen Food Development Recalls Lidl Branded Chopped Spinach Because of Possible Health Risk
Frozen Food Development is voluntarily recalling specific lots of Lidl branded 12-ounce packages of Frozen Chopped Spinach because the product 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.
The recalled Frozen Chopped Spinach was distributed in Lidl retail stores in GA, SC, NC, VA, MD, DE, NY, NJ, and PA.
The product comes in 12-ounce poly bags, and items included in the recall are marked with lot # R17742 or R17963 on the back of the poly bag with a best by date of 09/10/23.
Amy’s Kitchen Voluntarily Issues Allergy Alert on Undeclared Milk in a Single Lot of Vegan Organic Rice Mac & Cheeze
Petaluma, California – Amy’s Kitchen is initiating a voluntary Class I recall of Lot 60J0421 of the Vegan Organic Rice Mac & Cheeze due to the potential of having trace amounts of milk, which is not declared on the product label. The company is recalling this single lot out of an abundance of caution to ensure the safety of consumers who have an allergy or sensitivity to milk. Such consumers should not eat Lot 60J0421 of the Vegan Organic Rice Mac & Cheeze to avoid the risk of a serious or life-threatening allergic reaction.
Lily’s Sweets Voluntarily Recalls Lily’s Peppermint Flavor Baking Chips Due to Undeclared Presence of Soy Lecithin
Lily’s Sweets, is voluntarily recalling 18,855 cases of 7-ounce Peppermint Flavor Baking Chips due to the presence of soy lecithin. People who have a severe allergy or sensitivity to soy should not consume these products.
The product was a limited holiday seasonal offering available exclusively at Walmart stores in the United States. The impacted products are identified in the table below. No other Lily’s products are included in this recall.
Poppies International Expands Voluntary Recall of Chocolate Enrobed and Cream Puff Products Due to Presence of Metal
Poppies International, Inc. of Battleboro, NC is expanding their voluntary recall to include the Taste of Inspirations Crème Puffs 30ct container, UPC 7 25439 99597 9, Lot # L2I5021 Best Before Date 06/08/23 that were made during December 7-10, 2021, due to the possible presence of small metal fragments. The issue was discovered during production. To date no injuries or incidents have been reported in connection with the recalled items. See below for product list, UPCs, and “best before” dates, which may be found on the side of the containers.
Moor Herbs Recalls “Angel Formula” Infant Formula Because of Possible Health Risk
Moor Herbs of Detroit, MI is recalling it's Angel Formula, because FDA testing determined that the product did not meet specific nutrition and labeling requirements for infant formula, even though it is marketed as such. When the product was tested, the iron, sodium, and potassium content were well over the maximum allowed, which could potentially lead to iron overload and/or electrolyte imbalances. In addition, the product did not have vitamin D, and a vitamin D deficiency can potentially lead to rickets, a softening and weakening of bones.
The recalled “Angel Formula” was sold through it's Detroit, Michigan retail store and nationwide through online sales via www.moorherbs.comExternal Link Disclaimer.
The product is sold in 16 fl. Oz. plastic bottles and the labeling does not have any UPC or lot codes. We began shipping this product in February of 2019 and all units in distribution are included in this recall.
Dole Fresh Vegetables, Inc. Announces Voluntary Recall for Certain Salads Processed at its Springfield, OH and Soledad, CA Facilities and Containing Iceberg Lettuce Due to Possible Health Risk from Listeria monocytogenes
FOR IMMEDIATE RELEASE –Monterey, CA–January 7, 2022–Dole Fresh Vegetables, Inc. is voluntarily recalling from the market all Dole-branded and private label packaged salads described below processed at its Springfield, OH and Soledad, CA production facilities containing iceberg lettuce, due to a possible health risk from Listeria monocytogenes.
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.
Products subject to the voluntary recall from Springfield, OH are identified by a product lot code beginning with the letter “W” and a “Best if Used By” date between December 22, 2021 and January 9, 2022. Products subject to the voluntary recall from Soledad, CA are identified by a product lot code beginning with the letter “B” and a “Best if Used By” date between December 23, 2021 and January 8, 2022. The product lot codes are located in the upper-right-hand corner of the package (see example below). Consumers who still have any of these products in their refrigerators are urged not to consume the product and to discard it immediately. No illnesses have been reported with the products being recalled to date.
World Health Products, LLC. Issues Allergy Recall on Undeclared Milk Allergen in Jetfuel Diuretic
World Health Products, llc. of Monroe, CT is recalling Jetfuel Diuretic UPC 859613000859, because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.
The GAT Sport Jetfuel Diuretic was distributed thru the GAT Sport online store, Amazon and “Nationwide” retail stores.
Medical Device Recalls
Oscor Inc. Issues Voluntary Worldwide Recall of Destino Twist Steerable Guiding Sheath Due to the Risk of the Device Hub Cap and Seal on the Proximal End of the Device Handle Detachment During Use
FOR IMMEDIATE RELEASE – January 10, 2022 – Palm Harbor, FL., Oscor Inc. is voluntarily recalling 14 lots of Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 down to the user level. The Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 have been found to have increased risk of the hub cap and seal on the proximal end of the device handle detaching during use.
RISK STATEMENT: The Destino Twist 14T Model DST1405525 & Guidestar 14F Model D141103 detachment of the hub cap and seal on the proximal could lead to bleeding at the proximal end of the device and/or air embolism for the patient during intracardiac, renal or other peripheral placements procedures.
Oscor Inc. has reported two (2) Medical Device Reports to the FDA related to detachment of hub cap and seal on the proximal end of the device handle. The recall is limited to the two model numbers and lot numbers outlined above. There are no other recalls associated with this product.
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