FDA Recalls February 3 - 9

Drug Recalls

Apotex Corp. Issues Voluntary Nationwide Recall of Enoxaparin Sodium Injection, USP Due to Mislabeling of Syringe Barrel Measurement Markings

Apotex Corp is voluntarily recalling two (2) batches of Enoxaparin Sodium Injection, USP to consumer level due to a packaging error resulting in some syringes barrels containing 150 mg/mL markings (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength) on the syringe barrel and vice versa. The packaging error was discovered during a customer complaint investigation. To date, Apotex has not received any reports of adverse events related to use of these two batches. The affected product is manufactured by Gland Pharma Limited, Hyderabad, India.

Health Hazard Assessment: Incorrect syringe barrel marking could lead to miscalculation and inaccurate dose administration to patients. In one recalled batch (batch CT003, strength 120 mg/0.8mL), if a consumer used a syringe with an incorrect barrel having markings associated with the l00 mg/mL barrel, patients could receive 3.75 mg of Enoxaparin, instead of 3 mg of Enoxaparin. In another recalled batch (batch CS008, strength 100 mg/mL), if a consumer used a syringe with an incorrect barrel having markings associated with the 150 mg/mL barrel, patients would receive 2 mg of Enoxaparin rather than 2.5 mg of Enoxaparin. Accidental overdosage following administration of enoxaparin sodium injection may lead to bleeding complications. Alternative, if the dose administered is less than prescribed, the patient may be subject to developing some blood clotting conditions.

Food & Beverage Recalls

Shenandoah Growers, Inc Issues a Limited, Voluntary Recall of Specific Imported Organic Basil Because of Potential Health Risk

Shenandoah Growers, Inc (Harrisonburg, VA) out of an abundance of caution, has issued a limited, voluntary recall of approximately 3240 units of branded fresh cut, packaged organic basil clamshells packed at its Indianapolis, Indiana location due to a possible health risk from Cyclospora.

Cyclosporiasis is an intestinal infection caused by the Cyclospora parasite. A person may become infected after ingesting contaminated food or water. Common symptoms include severe abdominal pain, watery diarrhea, nausea and vomiting, body aches and fatigue. The infection is treated with antibiotics and most people respond quickly to treatment.

Ocean Beauty Seafood LLC Issues Allergy Alert on Undeclared Soy in Publix Brand Parmesan-Crusted Wild Alaskan Salmon Fillets 12 Oz. Package

Ocean Beauty Seafood LLC of Seattle, WA is recalling 8450 packages of Publix brand Parmesan-Crusted Wild Alaskan Salmon Fillets, net wt.12oz, frozen, UPC 41415 30245 7, because it may contain undeclared soy due to mis-packaging. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume this product.

The affected Parmesan-Crusted Wild Alaskan Salmon Fillets retail box bears the code date “Best Before/Use By date 021122”, and the affected Teriyaki sauced product is observed through a clear inner vacuum package inside the retail box. Images of the affected and non-affected product are found below.

The affected product was distributed directly to Publix Super Markets Inc distribution warehouses located in Florida and Georgia between 9/18/20 and 11/4/20. Publix further distributed product to their various retail stores in the southeast.