D-0261-2021 Class I Ongoing
FDA drug recall D-0261-2021 was initiated by Apotex Corp. on Feb 2, 2021 and is designated Class I. Reason for recall: Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength) The recall status is ongoing. Affected quantity: 6670 cartons.
Recall details
- Product Type
- Drugs
- Report Date
- Feb 17, 2021
- Initiation Date
- Feb 2, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6670 cartons
Product description
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 UPC 360505079544 (carton) NDC 60505-0795-1 UPC (01)10360505079510 (label)
Reason for recall
Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength)
Distribution pattern
Nationwide
Code information
Batch: CS008 Exp. 04/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0261-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026