FDAClass IApril 12, 2017

Vancomycin Hydrochloride for Injection recall: Particulate Matter

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

Why was Vancomycin Hydrochloride for Injection 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 591053A, Exp 11/1/2017

Product
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
Recalling firm
Hospira Inc., A Pfizer Company
Quantity
30,880 vials
Distribution
U.S. Nationwide
Recall date
April 12, 2017
Classification
Class I
Status
Terminated
Agency
FDA (drug)
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