Enoxaparin Sodium — Class III drug recall D-0153-2018
Terminated recall by Sanofi-Aventis U.S. LLC, reported 2018-01-17, distributed nationwide. Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found packaged in a
| Recall number | D-0153-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sanofi-Aventis U.S. LLC, Bridgewater, NJ, United States |
| Recall initiated | 2017-12-05 |
| Classified | 2018-01-05 |
| Reported by FDA | 2018-01-17 |
| Terminated | 2019-10-11 |
| Distributed | Nationwide (US) |
| Reason classes | labeling, potency |
| NDC | 00955-1012-10 |
| Lot numbers | 7S572 |
| Expiration dates | 2019-04 |
Product
Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count cartons, Rx Only, Winthrop US., a business of Sanofi-aventis, U.S. LLC Bridgewater, NJ 08807, NDC 0955-1012-10
Reason for recall
Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found packaged in a blister labeled as 120 mg/mL
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-0153-2018. 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.