Ampicillin and Sulbactam for Injection recall: Sterility Concern
Ampicillin and Sulbactam for Injection, USP 3 grams vials, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-242-41
Why was Ampicillin and Sulbactam for Injection recalled?
Lack of Assurance of Sterility
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lots within expiry.
- Product
- Ampicillin and Sulbactam for Injection, USP 3 grams vials, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-242-41
- Recalling firm
- Astral SteriTech Private Ltd.
- Quantity
- 91,860 vials
- Distribution
- Nationwide within the United States
- Recall date
- May 24, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)