FDA-Drug2017-04-12Class I

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

Hospira Inc., A Pfizer Company
Hazard

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.

Sold states
U.S. Nationwide
Affected count
30,880 vials
Manufactured in
275 N Field Dr, N/A, Lake Forest, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0638-2017

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