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Class III: unlikely to cause harmTerminated

Sandoz Ceftriaxone for Injection Recall

Ceftriaxone for Injection, USP, 1 gram, 10 Single use Vials, Rx only, For IM or I

Sandoz Inc · Princeton, NJ

Risk level
Class III
Reported by FDA
Nov 30, 2016
Recall ID
D-0145-2017
Check your lot numberHow we source this data

Summary

Sandoz recalled Ceftriaxone for Injection starting Oct 19, 2016. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0145-2017 on Nov 30, 2016. Reason: Labeling: Missing Label. Status: Terminated.

Why it was recalled

Labeling: Missing Label

Product description

Ceftriaxone for Injection, USP, 1 gram, 10 Single use Vials, Rx only, For IM or I.V. Use, Manufactured by: Sandoz GMbH for Hospira Worldwide, Inc., Lake Forest, Il 60045, USA, Made in Austria, NDC 0409-7332-01

Lot numbers, UPCs & expiration codes

Sandoz - Lot GJ7151(Pfizer- Lot 670028M); Exp. 07/19

Where it was sold

WI

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-0145-2017
Classification
Class III
Status
Terminated
Recall initiated
Oct 19, 2016
FDA report date
Nov 30, 2016
Quantity
139,430 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Sandoz Inc

Original FDA data

Every field from FDA enforcement report D-0145-2017, exactly as published.

Show all FDA fields
City
Princeton
State
NJ
Status
Terminated
Country
United States
Event ID
75563
Address
100 College Rd W
Code information
Sandoz - Lot GJ7151(Pfizer- Lot 670028M); Exp. 07/19
Postal code
08540-6604
Report date
Nov 30, 2016
Product type
Drugs
Recall number
D-0145-2017
Classification
Class III
Recalling firm
Sandoz Inc
Product quantity
139,430 vials
Termination date
Jul 27, 2017
Reason for recall
Labeling: Missing Label
Voluntary / mandated
Voluntary: Firm initiated
Product description
Ceftriaxone for Injection, USP, 1 gram, 10 Single use Vials, Rx only, For IM or I.V. Use, Manufactured by: Sandoz GMbH for Hospira Worldwide, Inc., Lake Forest, Il 60045, USA, Made in Austria, NDC 0409-7332-01
Distribution pattern
WI
Recall initiation date
Oct 19, 2016
Initial firm notification
Letter
Center classification date
Nov 19, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0145-2017, published Nov 30, 2016. 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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