Hospira Inc., A Pfizer Company recalls Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - Not For Direct Infusion, For Intravenous…

Recall date

January 24, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0638-2017

FDA classification

Class I

Brand / firm

Hospira Inc., A Pfizer Company

Sold / distributed

U.S. Nationwide

Why it was recalled

Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. The hair came in contact with the reconstituted drug product.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - Not For Direct Infusion, For Intravenous Use, packaged in 100 mL glass vial, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6510-01