Drug recall: Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count cartons, Rx Only, Winthrop US., a…

Class III FDA enforcement event 78637. Recall start date: 5 Dec 2017. Status in the FDA record: Terminated. Termination date: 11 Oct 2019.

Reason for recall, in the words of FDA

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

Class III, in the words of FDA

a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences

Sanofi-Aventis U.S. LLC started this drug recall on 5 Dec 2017. The firm address in the FDA record is in Bridgewater, NJ. FDA put the recall in Class III. FDA event 78637 has 1 product record. The first FDA enforcement report date is 17 Jan 2018. The record gives the status Terminated, with the termination date 11 Oct 2019.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Distributed nationwide.

Recalling firm

Sanofi-Aventis U.S. LLC, Bridgewater, NJ.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 78637: product records
Recall number	Product	Quantity	Class	Status	Report date
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, U.S. LLC Bridgewater, NJ 08807, NDC 0955-1012-10	11,474 cartons of 10 syringes per carton	Class III	Terminated	17 Jan 2018

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class III: The lowest of the three FDA recall classes.

The event in context

Drug events that started in 2017: 343
Share of these events in Class III: 30%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 10

Other events of the firm

Other FDA enforcement events of Sanofi-Aventis U.S. LLC
Initiated	Product (first record)	Type	Class	Records
11 Apr 2023	Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgewa	Drug	Class II	1
10 Aug 2020	Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC	Drug	Class II	1
22 Oct 2019	Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, C	Drug	Class II	12
5 Jul 2018	Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL prefilled pens, 1 pen per	Drug	Class II	1
27 Apr 2018	Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. a business of Sanofi-Aventis U.S. LLC., NDC	Drug	Class II	1
13 Oct 2017	Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: Teva Pharmachemle, Swensweg 5, Haarlem, The	Drug	Class III	1
12 Jun 2017	Gaviscon (Alumina & Magnesium Trisilicate) Regular Strength Original Flavor Chewable Tablets, 80 mg & 14.2 mg, 100-count	Drug	Class III	1
1 Sep 2016	Mozobil (plerixafor injection) 24mg/1.2mL (20mg/mL), For Single Use Only, Rx Only, Manufactured by: Genzyme Corporation	Drug	Class III	1
28 Oct 2015	Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0025-5833-02)	Drug	Class I	2

Sanofi-Aventis U.S. LLC: all 10 events

Official channels

FDA enforcement report D-0153-2018The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 78637. https://recallregister.com/fda/iii/78637/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Distributed nationwide.
What quantity of product is in FDA event 78637?: The FDA record gives this quantity: 11,474 cartons of 10 syringes per carton
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2017 have the same class?: 30% of the 343 drug events that started in 2017 are in Class III.