May 5

Category: 

Drug Recalls

Hospira Issues A Voluntary Nationwide Recall for One Lot of 0.5% Bupivacaine Hydrochloride Injection, USP and One Lot of 1% Lidocaine HCl Injection, USP Due to Mislabeling

Hospira, Inc., a Pfizer company, is voluntarily recalling lot EG6023 of 0.5% Bupivacaine Hydrochloride Injection, USP 30 mL and lot EG8933 of 1% Lidocaine HCl Injection, USP 30 mL, to the hospital/institution level due to mislabeling whereby a portion of each lot was incorrectly labeled as the other product. This issue was identified as part of the investigation of a confirmed customer report.

Hospira’s assessment of the potential risk to patients concluded that the use of the impacted product is likely to cause adverse events of moderate to high severity. If 1% lidocaine is administered to the patient instead of 0.5% bupivacaine, the patient may be underdosed, leading to lack of efficacy with potential outcomes such as inadequate pain management, and failure of surgical anesthesia. If 0.5% bupivacaine is administered to the patient instead of 1% lidocaine, an overdose of bupivacaine may occur, which could lead to potential outcomes such as seizures; respiratory abnormalities including low oxygen and/or elevated carbon dioxide in the blood, too much acid in the body fluids, and temporary cessation of breathing; heart abnormalities such as heart contraction and/or relaxation issues, irregular heartbeat, slower than normal heart rate, abnormal heart rhythm in which the ventricles of the heart quiver instead of pumping normally, cardiac arrest and cardiac flatline.

Hospira Issues A Voluntary Nationwide Recall for One Lot of Sterile Water for Injection, USP, Due to the Potential Presence of Visible Particulate

Hospira, Inc., a Pfizer company, is voluntarily recalling lot DN9185 of Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial, to the hospital/institution level due to a confirmed customer report for a single vial with a visible particulate.

Hospira’s  assessment of the potential risk to patients concluded that in rare instances the use of the impacted product can be associated with potential adverse events such as anaphylaxis, fever,    gastrointestinal disturbances, vein irritation, localized vein inflammation, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, and infarction.

Acella Pharmaceuticals, LLC, Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid® (Thyroid Tablets, USP) Due to Sub Potency

Acella Pharmaceuticals, LLC, is voluntarily recalling certain lots listed in the Tables 1 and 2 below of 15-mg, 30-mg, 60-mg, 90-mg and 120-mg NP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because routine testing has found these lots to be sub potent. The product contains less than 90% of the labeled amount of liothyronine (T3) and/or levothyroxine (T4).

Scentsational Soaps & Candles, Inc. Issues Voluntary Nationwide Recall of Scented Hand Sanitizers Due to the Presence of Methanol (Wood Alcohol), Benzene and Acetaldehyde

Scentsational Soaps & Candles, Inc., is voluntarily recalling 5 lots of Scentsational Soaps & Candles scented Hand Sanitizers from the Black and White Collection and Photo Real Collection and 3 lots of Ulta Beauty Collection scented Hand Sanitizer Spray packaged in 3.38 and 3.4 fluid ounce spray bottles, respectively, to the consumer level. See products listed in the table below. These products are being recalled after testing conducted by our firm revealed the presence of methanol (wood alcohol), benzene, and acetaldehyde. These products were distributed nationwide in the USA through Ulta Beauty, TJ Maxx, and Marshalls retail stores.

Food & Beverage Recalls

Russ Davis Wholesale Issues Allergy Alert on Undeclared Soy in Veggie Pizza

Russ Davis Wholesale of Wadena, Minnesota is voluntarily recalling Veggie Pizza under the Crazy Fresh and Quick & Easy brands as it may contain undeclared soy. People who have an allergy or sever sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume this product.

Crazy Fresh and Quick & Easy brand Veggie Pizza 6.2 oz, in a clear clam shell, sold in grocery stores located in Iowa, Michigan, Minnesota, North Dakota, South Dakota and Wisconsin. Product with Sell By dates of 04/20/21 through 05/04/21 are impacted by this Recall.

Evolve Issues Allergy Alert on Undeclared Soy in Vanilla Bean and Double Chocolate 4 Pack Protein Shakes

CytoSport, Inc., the manufacturer of Evolve, today announced a voluntary recall of specific lots of Evolve Protein Shakes after a third-party supplier was found to have supplied ingredients cross-contaminated with soy protein. CytoSport is initiating the voluntary recall to protect public health. Consumers that have an allergy or severe sensitivity to soy run the risk of an allergic reaction if they continue to consume the products.

Basic Grain Products, Inc. Issues Allergen Alert on Undeclared Milk in Caramel Rice Cakes

Basic Grain Products, Inc. in Coldwater, Ohio, is voluntarily recalling 6.56-ounce bags of Kroger and Stop & Shop brand’s Caramel Rice Cakes because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume this product. Individuals exhibiting signs or symptoms of foodborne illness or allergies should contact a physician immediately.

The product comes in a 6.5-ounce bag. The Best if Used By or Best Before date (also the Lot Code) is located on the plastic Kwik Lok tag at the top of the bag. Only two lots of the product are affected.

Velvet Ice Cream Recalls Various Products Due to Possible Listeria Risk

Velvet Ice Cream has announced it is voluntarily recalling all of its ice cream and sherbet products made on or after March 24, 2021 as a precaution because they have 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.