Recalls / Class II
Class IID-0095-2019
Product
Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Sterile, Rx Only, Manufactured for: Hospira, Inc., Lake Forest, IL 60045, USA. NDC carton: 0409-3506-01; NDC vial: 0409-3506-11
- Affected lot / code info
- Lot: 609G047, EXP 10/2018
Why it was recalled
Lack of assurance of sterility: loss of container integrity.
Recalling firm
- Firm
- Pfizer Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 E 42nd St, N/A, New York, New York 10017-5703
Distribution
- Quantity
- 71,075 vials
- Distribution pattern
- Nationwide in the US and Puerto Rico
Timeline
- Recall initiated
- 2018-09-20
- FDA classified
- 2018-10-24
- Posted by FDA
- 2018-10-31
- Terminated
- 2022-09-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0095-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.