Pfizer Recalls Sterile Water for Injection Vials Due to Cracked Glass
Pfizer is recalling 18,725 vials of Sterile Water for Injection due to cracked or chipped glass at the neck, which poses a non-sterility risk.
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. According to the rubric, an FDA Class II recall involving a significant risk of harm (non-sterility of an injectable product) corresponds to a 'Severe' rating (Score 4), particularly given the potential for serious injury from contaminated injections.
Plain-English summary
Pfizer Inc. is recalling 18,725 vials of Sterile Water for Injection, USP Single Dose 100 mL vials (NDC 50242-901-24). The product was manufactured by Hospira, Inc. for Genentech, Inc. and distributed nationwide in the USA. The specific lot affected is 63-075-DK, with an expiration date of February 2019.
The recall was initiated because of non-sterility issues caused by cracked or chipped glass at the neck of the vials. This defect compromises the integrity of the sterile barrier, potentially allowing contamination.
Healthcare providers and patients should stop using the affected vials immediately. Consumers should check their inventory for the specific lot number and expiration date listed above and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Sterile Water for Injection, USP Single Dose 100 mL vials, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 USA for Genentech, Inc., South San Francisco, CA 94080-4990. NDC 50242-901-24
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Injectable Solution
- Affected units
- 18,725
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 (1)
- Lot: 63-075-DK Exp. FEB 2019
Distribution
Distributed nationwide across the United States.
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