Enoxaparin Sodium Injection — Class I drug recall D-0261-2021
Ongoing recall by Apotex Corp., reported 2021-02-17, distributed nationwide. Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL st
| Recall number | D-0261-2021 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apotex Corp., Weston, FL, United States |
| Recall initiated | 2021-02-02 |
| Classified | 2021-02-17 |
| Reported by FDA | 2021-02-17 |
| Distributed | Nationwide (US) |
| Quantity | 6,670 cartons |
| Reason classes | labeling, potency |
| UPC / GTIN / UDI-DI | 00360505079544, 10360505079510 |
| NDC | 60505-0795-01, 60505-0795-04 |
| Lot numbers | CS008 |
| Expiration dates | 2022-04 |
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 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)
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0261-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.