The National Agency for Food and Drug Administration and Control (NAFDAC) has received information from the US FDA that Apotex Corp is voluntarily recalling two (2) batches of Enoxaparin Sodium Injection, USP 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.
Enoxaparin Sodium injection is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), Treatment of Acute Deep Vein Thrombosis, prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin and Treatment of Acute ST-Segment Elevation Myocardial Infarction.
Incorrect syringe barrel marking could lead to miscalculation and inaccurate dose administration to patients. Accidental overdosage following administration of enoxaparin sodium injection may lead to bleeding complications. Alternatively, if the dose administered is less than prescribed, the patient may be subject to developing some blood clotting conditions.
The affected Enoxaparin Sodium Injection, USP is manufactured by manufactured by Gland Pharma Limited, Hyderabad, India and has the following details:
|Product||Enoxaparin Sodium Injection, USP|
|Strength||100 mg/mL||120 mg/0.8mL|
|Syringe Barrel Measurement Markings||100 mg/mL||150 mg/ mL|
|Pack Size||10 x 1mL Single Dose Syringes||10 x 0.8 mL Single Dose Syringes|
|NDC Number on Carton||60505-0795-4||60505-0796-4|
|NDC Number On label||60505-0795-1||60505-0796-0|
|UPC Code on Carton||360505079544||360505079643|
|UPC Code on label||(01)10360505079510||(01)10360505079602|
Healthcare providers with an existing stock of the recalled products are encouraged to:
- Stop dispensing or distributing the products immediately and quarantine the products.
- Return unused products to the nearest NAFDAC office for regulatory action.