Why it was recalled
Lack of Assurance of Sterility
Product description
Ampicillin for Injection, USP 2g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-223-41
Lot numbers, UPCs & expiration codes
All lots within expiry.
Where it was sold
Nationwide within the United States
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-0583-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 15, 2023
- FDA report date
- May 24, 2023
- Quantity
- 45,160 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Astral SteriTech Private Ltd.
Original FDA data
Every field from FDA enforcement report D-0583-2023, exactly as published.
Show all FDA fields
- City
- Vadodara
- Status
- Terminated
- Country
- India
- Event ID
- 92341
- Address
- 911 G I D C Makarpura
- Code information
- All lots within expiry.
- Report date
- May 24, 2023
- Product type
- Drugs
- Recall number
- D-0583-2023
- Classification
- Class II
- Recalling firm
- Astral SteriTech Private Ltd.
- Product quantity
- 45,160 vials
- Termination date
- Apr 5, 2024
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ampicillin for Injection, USP 2g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-223-41
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- May 15, 2023
- Initial firm notification
- Letter
- Center classification date
- May 18, 2023