FDA Recalls on Drugs
Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Two Lots of NP Thyroid®, Thyroid Tablets, USP Due to Sub Potency
Acella Pharmaceuticals, LLC is voluntarily recalling one lot of 15-mg and one lot of 120-mg NP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because testing has found these lots to be sub potent. The product may have as low as 87% of the labeled amount of levothyroxine (T4).
FDA Recalls on Medical Devices
BD Announces FDA Classifications for August 4th Recalls of BD Alaris™ System Hardware for Keypads, Incorrect Module Types and/or Sizes, and Channel Error
BD initiated the voluntary recalls to notify customers of the potential for four hardware situations that may result in the infusion pump not operating as expected. BD has provided instructions to correct and/or mitigate the situations. The four recalls include:
Alaris PC Unit Model 8015 Front Case with Keypad Replacement Kits (Recall 1 – Class I): The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress, potentially resulting in a delay to the start of infusion, interruption of infusion or inability to titrate medication.
Alaris Pump Module Model 8100 Front Case with Keypad Replacement Kits (Recall 2 – Class I): Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress, potentially resulting in a delay to the start of infusion or interruption of infusion.
BD Alaris™ Syringe Module Model 8110 and PCA Module Model 8120 (Recall 3 - Class I): The Alaris PC unit may display incorrect syringe type and/or syringe sizes. This could potentially result in delays in infusion, under-infusion or over-infusion.
BD Alaris™ EtCO2 Module model 8300 channel error (Recall 4 – Class II): Infusion pump component defect may result in interruption of patient monitoring.
FDA Recalls on Food & Beverages
GHSW, LLC. is voluntarily recalling 1512 units of Trader Joe’s Southwest Style Sweet Potato Sauté Bowl due to undeclared milk and egg allergens in the dressing that are not declared on the label. People who are allergic to milk and eggs run the risk of serious or life-threatening allergic reaction if they consume this product.
The recalled product(s) were shipped to 36 Trader Joe’s stores in the following states: AR, CO, KS, LA, NM, OK, TN, and TX.
The recall has been isolated to only Southwest Style Sweet Potato Sauté Bowl with the Best By dates 09/23/20, 09/24/20, 09/25/20, 09/26/20, and 09/28/20 on the front of the package. No other products or lots are affected by this recall.
Homestead Creamery of Wirtz, VA is recalling one lot of Homestead Creamery chocolate ice cream quarts, dated 5/13/2021, because it may contain undeclared pecans. People who have an allergy or severe sensitivity to pecans run the risk of serious or life-threatening allergic reaction if they consume these products.
The chocolate ice cream quarts were distributed in Virginia and North Carolina in May through retail stores and direct delivery.
FDA Recalls on Animal & Veterinary
Real Pet Food Company is voluntarily recalling Billy+Margot Wild Kangaroo and Superfoods Recipe 4lb bags because it has the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products.
Pets with Salmonella infections may be lethargic and have diarrhea, fever, vomiting and or abdominal pain. Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.
You can find all FDA recalls at the FDA website.