Why it was recalled
Presence of Particulate Matter: particulate matter identified after reconstitution.
Product description
Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only, 10 vials/carton, Made in Italy Distributed by Roerig Division of Pfizer Inc. New York, NY 10017 vial NDC 0049-0013-81, carton NDC 0049-0013-83
Lot numbers, UPCs & expiration codes
Lot # 3301612, EXP 02/2022
Where it was sold
Distributed Nationwide in the US
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-1306-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 29, 2020
- FDA report date
- Jun 17, 2020
- Quantity
- 94320 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-1306-2020, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 85754
- Address
- 235 E 42nd St
- Code information
- Lot # 3301612, EXP 02/2022
- Postal code
- 10017-5703
- Report date
- Jun 17, 2020
- Product type
- Drugs
- Recall number
- D-1306-2020
- Classification
- Class II
- Recalling firm
- Pfizer Inc.
- Product quantity
- 94320 units
- Termination date
- Jan 13, 2022
- Reason for recall
- Presence of Particulate Matter: particulate matter identified after reconstitution.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only, 10 vials/carton, Made in Italy Distributed by Roerig Division of Pfizer Inc. New York, NY 10017 vial NDC 0049-0013-81, carton NDC 0049-0013-83
- Distribution pattern
- Distributed Nationwide in the US
- Recall initiation date
- May 29, 2020
- Initial firm notification
- Letter
- Center classification date
- Jun 12, 2020