Apotex Corp announced the voluntary recall of 2 batches of Enoxaparin Sodium Injection, USP, due to a packaging error resulting in some syringe barrels containing 150mg/mL markings (corresponding to 120mg/0.8mL strength) instead of 100mg/mL markings (corresponding to 100mg/mL strength) and vice versa.
Enoxaparin sodium injection is a low molecular weight heparin indicated for the prophylaxis of deep vein thrombosis (DVT), treatment of acute DVT with or without pulmonary embolism (PE), prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction (MI) when concurrently administered with aspirin, and treatment of acute ST-segment elevation MI.
According to Apotex Corp, “the incorrect syringe barrel markings could lead to miscalculation and inaccurate dose administration to patients.” Patients exposed to a higher dose may be subject to bleeding complications, and alternatively, patients exposed to a lower dose may be subject to developing blood clotting conditions.
The 2 recalled batches of Enoxaparin Sodium Injection were distributed nationwide to wholesalers and warehousing chains, and include the following:
- Enoxaparin 100mg/mL (Syringe Barrel Marking 100mg/mL); Batch# CS008; NDC# on Carton 60505-0795-4; NDC# on Label 60505-0795-1.
- Enoxaparin 120mg/0.8mL (Syringe Barrel Marking 150mg/mL); Batch# CT003; NDC# on Carton 60505-0796-4; NDC# on Label 60505-0796-0.
At this time, the Company has not received any adverse event reports related to this recall. Adverse reactions related to this recall should be reported to the FDA’s MedWatch program.
For more information regarding his recall contact Apotex Corp, by calling (800) 706-5575 or emailing [email protected].
Apotex Corp. issues voluntary nationwide recall of Enoxaparin Sodium Injection, USP due to mislabeling of syringe barrel measurement markings. [press release]. Weston, FL: Apotex Corp.; February 2, 2021.