Drug Safety Alerts

Bupivacaine hydrochloride injection (2.5 mg/mL) 0.25% vials Class I Recall

12/28/2016

On December 28, 2016, the United States Food and Drug Administration (FDA) issued a notice regarding Class I recall of bupivacaine hydrochloride injection (2.5 mg/mL) 0.25% vials. This recall was issued due to the presence of particulate matter within a single vial. In the 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 59-064-DK exp. 11/01/17. No other lots are affected by this recall.

This recall was originally issued on August 5, 2016 to the retail-level. The FDA classified this as a Class I recall on December 28, 2016.

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 Medical Communications at 1-800-615-0187. 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.