Drug Safety Alerts

Vancomycin Hydrochloride for Injection 750 mg Class I Recall

12/27/17

On December 27, 2017, the United States Food and Drug Administration (FDA) issued a notice regarding a Class I recall of Vancomycin Hydrochloride for Injection 750 mg manufactured by Pfizer Inc. This recall was issued due to the presence of a particulate matter, confirmed as glass, within a single vial. In the event the particulate is administered to a patient, it may result in phlebitis, end-organ granuloma or micro-embolic effects, or gastrointestinal trauma. The risk is reduced by the possibility of detection, as the label contains a clear statement directing the healthcare professional to visually inspect the product for particulate matter and discoloration prior to administration.

This recall affects lot number 632153A exp. 03/01/2018. No other lots are affected by this issue.

Please note: This recall was originally issued to the retail-level on August 31, 2017. The FDA classified this as a Class I recall on December 27, 2017.

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

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

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