Class II · Moderate risk Terminated
Ampicillin and Sulbactam for Injection
Reason Lack of Assurance of Sterility
Ampicillin for Injection
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.
What was recalled
Ampicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78) packaged in 10-count shrink wrap packs (NDC 0781-3407-95), Rx only, Manufactured in Austria by Sandoz GmbH or Sandoz Inc., Princeton, NJ 08540.
- Recalling firm
- Sandoz Inc
- NDC code
- 0781-3407-78
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1179-2017
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Ampicillin recalls
See all
Class II · Moderate risk Terminated
Ampicillin and Sulbactam for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ampicillin and Sulbactam for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ampicillin and Sulbactam for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ampicillin and Sulbactam for Injection
Reason Lack of Assurance of Sterility
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