Pfizer Recalls Vancomycin Hydrochloride Vials Due to Glass Particulate Matter
Pfizer Inc. is recalling 102,500 vials of Vancomycin Hydrochloride for Injection due to the presence of glass particulate matter.
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: The source text explicitly identifies the agency classification as Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Pfizer Inc. is recalling 102,500 vials of Vancomycin Hydrochloride for Injection, USP, 750 mg, sterile powder. The recall is being conducted because glass particulate matter was found in the vials. The affected product is identified by Lot 632153A with an expiration date of 03/18.
The recalled product was distributed nationwide in the United States and Puerto Rico. The product is a prescription-only medication intended for intravenous use. The manufacturer of record is Hospira, Inc., located in Lake Forest, IL.
Healthcare providers and patients should stop using the affected product and contact their healthcare provider or pharmacist for further instructions. The recall is classified as Class I by the FDA.
The recalled product
- Product
- VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
- Brand
- VANCOMYCIN HYDROCHLORIDE
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 102,500
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: 632153A
- Exp. 03/18
Distribution
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