The Recall Desk
CriticalFDA (Drugs)·D-0123-2018·Announced 2017-12-27

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.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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.
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

Distributed nationwide across the United States.

The notice also names 1 state specifically: