Pfizer Recalls Meropenem Injection Due to Loss of Sterility Assurance
Pfizer is recalling 71,075 vials of Meropenem for Injection because the containers may have lost integrity, compromising sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a loss of sterility assurance in an intravenous medication, which poses a significant risk of serious injury or infection.
Plain-English summary
Pfizer Inc. is recalling 71,075 vials of Meropenem for Injection, USA (I.V.), 1 gram/vial. The recall is due to a lack of assurance of sterility caused by a loss of container integrity. The affected product is identified by Lot 609G047 with an expiration date of 10/2018.
The product was distributed nationwide in the US and Puerto Rico. It is a sterile, prescription-only medication manufactured for Hospira, Inc. The NDC numbers are 0409-3506-01 for the carton and 0409-3506-11 for the vial.
Healthcare providers and patients should stop using the affected product and contact Pfizer or their healthcare provider for further instructions.
The recalled product
- 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
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Antibiotic Injection
- Affected units
- 71,075
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 609G047
- EXP 10/2018
Distribution
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