Recalls / Class II
Class IID-0598-2023
Product
Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-208-15
- Affected lot / code info
- All lots within expiry.
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Astral SteriTech Private Ltd.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 911 G I D C Makarpura, N/A, Vadodara, N/A N/A, India
Distribution
- Quantity
- 11,555 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2023-05-15
- FDA classified
- 2023-05-18
- Posted by FDA
- 2023-05-24
- Terminated
- 2024-04-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0598-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.