Why it was recalled
Lack of Assurance of Sterility
Product description
Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-005-20
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-0592-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 15, 2023
- FDA report date
- May 24, 2023
- Quantity
- 236,610 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Astral SteriTech Private Ltd.
Original FDA data
Every field from FDA enforcement report D-0592-2023, 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-0592-2023
- Classification
- Class II
- Recalling firm
- Astral SteriTech Private Ltd.
- Product quantity
- 236,610 vials
- Termination date
- Apr 5, 2024
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-005-20
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- May 15, 2023
- Initial firm notification
- Letter
- Center classification date
- May 18, 2023