Apotex Recalls Enoxaparin Syringes Due to Labeling Mixup
Apotex Corp. is recalling Enoxaparin Sodium Injection syringes because some barrels may display incorrect concentration markings, posing a risk of dosing errors.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which per the rubric mandates a score of 5 (Critical) regardless of other factors, as it indicates a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Apotex Corp. is recalling Enoxaparin Sodium Injection, USP 120 mg/0.8 mL Single Dose Syringes with Automatic Safety Device. The recall involves 6,832 cartons of the product, which was distributed nationwide. The specific batch affected is CT003 with an expiration date of 05/2022.
The recall was initiated due to a labeling mixup. Some syringe barrels may contain markings for 100 mg/mL strength instead of the correct 150 mg/mL strength (which corresponds to the 120 mg/0.8 mL dose). This discrepancy could lead to incorrect dosing if the markings are relied upon for administration.
Healthcare providers and patients should check their inventory for the affected NDC 60505-0796-4 and batch CT003. If found, the product should be quarantined and not used. Patients should consult their healthcare provider for alternative treatment options if they have been using the affected product.
The recalled product
- Product
- Enoxaparin Sodium Injection, USP 120 mg/ 0.8 mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection 10 x 0.8 mL Single Dose Syringes Rx Only,Manufactured by: Gland Pharma Ltd. Hyderabad, India Manufactured for: Apotex Corp. Weston, FL 33326 NDC 60505-079
- Manufacturer
- Apotex Corp.
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 6,832
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Batch: CT003 Exp. 05/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Apotex Corp. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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