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
Reported: October 31, 2018 Initiated: September 20, 2018 #D-0095-2019
Product Description
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
Reason for Recall
Lack of assurance of sterility: loss of container integrity.
Details
- Recalling Firm
- Pfizer Inc.
- Units Affected
- 71,075 vials
- Distribution
- Nationwide in the US and Puerto Rico
- Location
- New York, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Pfizer Inc.. Units affected: 71,075 vials.
Why was this product recalled? ▼
Lack of assurance of sterility: loss of container integrity.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 31, 2018. Severity: Moderate. Recall number: D-0095-2019.
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