CLASS III Drug recall · Reported 17 Jan 2018 · FDA Enforcement Report
Enoxaparin Sodium, Injection 120 mg/, pre-filled recalled
Sanofi-Aventis U.S is recalling Enoxaparin Sodium, Injection 120 mg/, pre-filled, distributed nationwide in the US. The recall was initiated on 5 Dec 2017 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0153-2018
- FDA event ID
- 78637
- Recalling firm
- Sanofi-Aventis U.S, Bridgewater, NJ
- Brand
- Enoxaparin Sodium
- Manufacturer
- Sanofi-Aventis U.S. LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 5 Dec 2017
- FDA classified
- 5 Jan 2018
- Reported
- 17 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Blood Thinners
Timeline
| 5 Dec 2017 | Recall initiated by company | |
| 5 Jan 2018 | Classified by FDA | +31 days |
| 17 Jan 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Distributed nationwide.
Questions about this recall
Why was it recalled?
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
Which lots are affected?
Lot #: 7S572, Exp. 04/2019
Where was it sold?
Distributed nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Sanofi-Aventis U.S
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Admelog, insulin lispro injection/mL (U-100) multi-dose vial recalledAdmelog | Sanofi-Aventis U.S | Sterility | Nationwide |
| Drug | CLASS II | Elitek (rasburicase) for injection, 7.5 mg vial recalledElitek | Sanofi-Aventis U.S | Potency & Assay | Nationwide |
| Drug | CLASS II | Regular Strength Zantac 150 mg recalled by Sanofi-Aventis U.S | Sanofi-Aventis U.S | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Zantac 75 mg recalled by Sanofi-Aventis U.S | Sanofi-Aventis U.S | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Regular Strength Zantac 150 mg recalled by Sanofi-Aventis U.S | Sanofi-Aventis U.S | Nitrosamine Impurity | Nationwide |
Other Enoxaparin recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Enoxaparin Sodium Injection, USP, 30 mg recalled by Cardinal HealthEnoxaparin Sodium | Cardinal Health | Packaging Defects | KS |
| Drug | CLASS II | Enoxaparin Sodium Injection recalled by Cardinal HealthcareEnoxaparin Sodium | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Enoxaparin Sodium Injection, USP, 40 mg recalled by Sandoz | Sandoz | Temperature Abuse | Nationwide |
| Drug | CLASS I | Enoxaparin Sodium Injection recalled by Apotex | Apotex | Packaging Defects | Nationwide |
| Drug | CLASS I | Enoxaparin Sodium Injection recalled by Apotex | Apotex | Packaging Defects | Nationwide |