Vancomycin Hydrochloride Injection Recalled for Glass Particulate Matter
Pfizer recalls approximately 89,700 vials of Vancomycin Hydrochloride for Injection due to glass particulate matter contamination. The recalled product (Lot 33045BA) was distributed across the USA and Puerto Rico.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is an FDA Class I recall, which the FDA applies to situations where there is reasonable probability that exposure will cause serious adverse health consequences or death.
Plain-English summary
Pfizer Inc. is recalling Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, a sterile powder for intravenous use. The specific product is supplied in single-dose flip-top vials (10 vials per carton), identified by vial NDC 0409-3515-11 and carton NDC 0409-3515-01, lot number 33045BA, with expiration date September 1, 2023.
The recall was prompted by detection of glass particulate matter in the injectable medication. Glass contamination in an intravenous product poses a serious risk if the contaminated medication is administered.
The affected product was distributed throughout the United States and in Puerto Rico. Approximately 89,700 vials are subject to this recall. The FDA has classified this as a Class I recall.
The recalled product
- Product
- VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
- Brand
- VANCOMYCIN HYDROCHLORIDE
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Injectable
- Affected units
- 89,700
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 (2)
- Lot: 33045BA
- EXP 1SEP2023
Distribution
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