Recalls / Class II
Class IID-1306-2020
Product
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
- Brand name
- Unasyn
- Generic name
- Ampicillin Sodium And Sulbactam Sodium
- Active ingredients
- Ampicillin Sodium, Sulbactam Sodium
- Route
- Intramuscular, Intravenous
- NDCs
- 0049-0013, 0049-0014
- FDA application
- NDA050608
- Affected lot / code info
- Lot # 3301612, EXP 02/2022
Why it was recalled
Presence of Particulate Matter: particulate matter identified after reconstitution.
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- Roerig
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 E 42nd St, N/A, New York, New York 10017-5703
Distribution
- Quantity
- 94320 units
- Distribution pattern
- Distributed Nationwide in the US
Timeline
- Recall initiated
- 2020-05-29
- FDA classified
- 2020-06-12
- Posted by FDA
- 2020-06-17
- Terminated
- 2022-01-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1306-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.