Pfizer Recalls Bacteriostatic Water Vials Due to Sterility Concerns
Pfizer is recalling 185,700 vials of Bacteriostatic Water for Injection due to a lack of assurance of sterility. The product was distributed nationwide in the US and Puerto Rico.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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, which corresponds to a Severe rating under the rubric, particularly given the risk of infection associated with non-sterile injectable products.
Plain-English summary
Pfizer Inc. is recalling 185,700 vials of Bacteriostatic Water for Injection, USP, 30 mL vials. The recall is being conducted due to a lack of assurance of sterility. The product is a prescription-only medication manufactured for Hospira, Inc. and is identified by Lot # W20308 with an expiration date of December 1, 2019.
The affected product was distributed nationwide in the United States and Puerto Rico. Bacteriostatic Water for Injection is used as a diluent for intramuscular, intravenous, or subcutaneous administration. The specific NDC codes for the vials and cartons are 0409-3977-01 and 0409-3977-03, respectively.
Healthcare providers and patients should stop using the affected product and contact Pfizer or their local FDA office for further instructions. No specific illnesses or injuries have been reported in the source text, but the lack of sterility assurance poses a potential risk of infection.
The recalled product
- Product
- BACTERIOSTATIC WATER (BACTERIOSTATIC WATER)
- Brand
- BACTERIOSTATIC WATER
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Injectable Diluent
- Affected units
- 185,700
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 (3)
- Lot #: W20308
- Exp. Dec 1
- 2019
Distribution
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