Pfizer Recalls Sterile Water Vials Due to Insect Particulate Matter
Pfizer is recalling 49,525 vials of Sterile Water for Injection because an insect was found in one vial. The product is distributed nationwide.
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 introducing foreign matter into the body via injection.
Plain-English summary
Pfizer Inc. is recalling 49,525 vials of Sterile Water for Injection, USP, 100 mL single-dose vials (NDC 0409-4887-25). The recall was initiated due to the presence of particulate matter, specifically an insect, identified in one vial.
The affected product is distributed nationwide in the United States. The specific lot number is DN9185. The product is a prescription-only drug diluent intended for intramuscular, intravenous, or subcutaneous use.
Healthcare providers and patients should stop using the affected lot and contact their healthcare provider or pharmacist for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- STERILE WATER (WATER)
- Brand
- STERILE WATER
- Manufacturer
- Pfizer Inc.
- Affected units
- 49,525
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 DN9185
Distribution
Distributed nationwide across the United States.
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