FDA Drug recall D-0153-2018
Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count cartons, Rx Only, Winthrop US., a business of Sanofi-aventis,…
- FDA Drug
- Class III
- terminated
- Published 2018-01-17
On 2018-01-17 the FDA classified a Class III recall of Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count cartons, Rx Only, Winthrop US., a business of Sanofi-aventis,… by Sanofi Aventis U S, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0153-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-12-05 |
| Published | 2018-01-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sanofi Aventis U S |
| Distribution | US |
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
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
Identifiers
| ndc | 0955-1003-01 |
|---|---|
| ndc | 0955-1003-10 |
| ndc | 0955-1004-01 |
| ndc | 0955-1004-10 |
| ndc | 0955-1006-01 |
| ndc | 0955-1006-10 |
| ndc | 0955-1008-01 |
| ndc | 0955-1008-10 |
| ndc | 0955-1010-01 |
| ndc | 0955-1010-10 |
| ndc | 0955-1016-01 |
| ndc | 0955-1012-01 |
| ndc | 0955-1012-10 |
| ndc | 0955-1015-01 |
| ndc | 0955-1015-10 |
| code_info | Lot #: 7S572, Exp. 04/2019 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Sanofi Aventis U S
- Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807 A San…
FDA Drug · Class II · 2023-05-24 · Sanofi Aventis U S - Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75
FDA Drug · Class II · 2020-08-26 · Sanofi Aventis U S - Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 3740…
FDA Drug · Class II · 2019-12-11 · Sanofi Aventis U S - Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's 41167-0300-0…
FDA Drug · Class II · 2019-12-11 · Sanofi Aventis U S - Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219
FDA Drug · Class II · 2019-12-11 · Sanofi Aventis U S
All Sanofi Aventis U S recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0153-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.