FDA Drug recall D-0286-2022
Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Rx Only
- FDA Drug
- Class I
- completed
- Published 2021-12-08
On 2021-12-08 the FDA classified a Class I recall of Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Rx Only by Sandoz, citing temperature Abuse; temperature excursion during shipping.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0286-2022 |
| Classification | Class I |
| Status | completed |
| Initiated | 2021-11-17 |
| Published | 2021-12-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sandoz |
| Distribution | US |
Product
Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Rx Only; 0.4 mL Syringes, Manufactured for Sandoz Inc., Princeton, NJ 08540, NDC 00781-3246-02; Carton (10 x 0.4 mL Syringes), Manufactured by Shenzhen Techdow Pharmaceutical Co., Ltd. Shenzhen City, Guangdong Province 518057, China for Sandoz Inc., Princeton, NJ 08540, NDC 00781-3246-64
Reason
Temperature Abuse; temperature excursion during shipping
Identifiers
| code_info | Lot #SAB06761A, exp 04/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0286-2022%22
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