Drug Safety Alerts

Vancomycin Hydrochloride for Injection, USP Class I Recall

4/12/2017

On April 12, 2017, the United States Food and Drug Administration (FDA) issued a notice regarding Class I Recall of vancomycin Hydrochloride for Injection, USP 10 grams 100 mL vial NDC # 00409-6510-01 manufactured by Hospira Inc., a Pfizer Company. This recall was issued due to the 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.

In the unlikely event that the particulate is administered to a patient, it may result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or low-level allergic response to the particulate. The risk is reduced by the possibility of detection, as the label contains a clear statement directing the physician to visually inspect the product for particulate matter and discoloration prior to administration.

This recall affects lot number 591053A exp. 11/01/2017. No other lot numbers are affected by this recall.

This recall was originally issued to the hospital/user-level on January 25, 2017. The FDA classified this as a Class I Recall on April 12, 2017.

CVS Caremark Response:

Please note: This product is not carried by the CVS Caremark Mail Service Pharmacies.

For more information about this recall, health care providers may contact Hospira Inc., a Pfizer Company toll-free at1-800-615-0187, Monday through Friday, 8:00 am through 7:00 pm (ET). You may also contact the FDA consumer inquiry line at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit https://www.accessdata.fda.gov.