Apotex Recalls Enoxaparin Syringes Due to Labeling Mixup
Apotex Corp. is recalling Enoxaparin Sodium Injection syringes because some barrels may display incorrect strength markings.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.
Plain-English summary
Apotex Corp. is recalling Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automatic Safety Device. The recall involves 6,670 cartons of the product, which was distributed nationwide. The specific batch affected is CS008 with an expiration date of 04/2022.
The recall was initiated due to a labeling mixup. Some syringe barrels may contain markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of the correct 100 mg/mL markings. This discrepancy could lead to dosing errors if the incorrect markings are relied upon.
Healthcare providers and patients should check their inventory for the affected NDC 60505-0795-4 and batch CS008. If the product is found, it should be quarantined and returned to the distributor or manufacturer according to standard recall procedures.
The recalled product
- Product
- Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection 10 x 1 mL Single Dose Syringes Rx Only, Manufactured by: Gland Pharma Ltd. Hyderabad, India Manufactured for: Apotex Corp. Weston, FL 33326 NDC 60505-0795-4…
- Manufacturer
- Apotex Corp.
- Category
- Drug — Injectable Anticoagulant
- Hazard
- Affected units
- 6,670
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: CS008 Exp. 04/2022
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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