February 19, 2021
Two batches of enoxaparin sodium injections are being recalled by Apotex Corp. because of incorrect dosage markings on some syringe barrels, according to the February 17, 2021, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects the following products, which were manufactured by Gland Pharma Limited and distributed throughout the United States:
- enoxaparin sodium injection, 120 mg/0.8 mL single-dose syringes with automatic safety device for subcutaneous injection, 10 x 0.8-mL single-dose syringes (carton NDC 60505-0796-4, label NDC 60505-0796-0), from batch CT003 (Exp. 5/22); and
- enoxaparin sodium injection, 100 mg/mL single-dose syringes with automatic safety device for subcutaneous injection, 10 x 1-mL single-dose syringes (carton NDC 60505-0795-4, label NDC 60505-0795-1), from batch CS008 (Exp. 4/22).
The mislabeled syringes were discovered through a customer report. According to Apotex Corp., some syringes have 150 mg/mL markings (corresponding to 120 mg/0.8 mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength) on the syringe barrel, and vice versa.
“Incorrect syringe barrel marking could lead to miscalculation and inaccurate dose administration to patients,” the company warned in a February 2, 2021, statement announcing the voluntary recall. “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.”
The FDA has not yet classified the recall. In the statement issued earlier this month, Apotex said it had not received any reports of adverse events related to use of the recalled syringes.
Enoxaparin sodium injection is a prescription blood thinner used to help prevent or treat blood clots.