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Class II: temporary or reversible health riskTerminated

Sanofi-Aventis U.S. Docetaxel injection concentrate Recall

Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U

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

Risk level
Class II
Reported by FDA
May 9, 2018
Recall ID
D-0804-2018
Check your lot numberHow we source this data

Summary

Sanofi-Aventis U.S. recalled Docetaxel injection concentrate starting Apr 27, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0804-2018 on May 9, 2018. Reason: Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed. Status: Terminated.

Why it was recalled

Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.

Product description

Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. a business of Sanofi-Aventis U.S. LLC., NDC 0955-1020-01

Lot numbers, UPCs & expiration codes

Lot #: 7F307A, 7F307C, Exp 01/2019

Where it was sold

US nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0804-2018
Classification
Class II
Status
Terminated
Recall initiated
Apr 27, 2018
FDA report date
May 9, 2018
Quantity
19580 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Sanofi-Aventis U.S. LLC

Original FDA data

Every field from FDA enforcement report D-0804-2018, exactly as published.

Show all FDA fields
City
Bridgewater
State
NJ
Status
Terminated
Country
United States
Event ID
79964
Address
55 Corporate Dr
Code information
Lot #: 7F307A, 7F307C, Exp 01/2019
Postal code
08807-1265
Report date
May 9, 2018
Product type
Drugs
Recall number
D-0804-2018
Classification
Class II
Recalling firm
Sanofi-Aventis U.S. LLC
Product quantity
19580 vials
Termination date
Jan 20, 2021
Reason for recall
Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. a business of Sanofi-Aventis U.S. LLC., NDC 0955-1020-01
Distribution pattern
US nationwide
Recall initiation date
Apr 27, 2018
Initial firm notification
Letter
Center classification date
May 14, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0804-2018, published May 9, 2018. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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