Hospira, Inc. has voluntarily recalled one lot of Preservative-Free Bupivacaine HCL Injection due to a risk of iron oxide particulate in glass vials.
About the Bupivacaine HCL Injection Recall
As reported by the U.S. Food and Drug Administration (FDA), there has been one confirmed report of iron oxide found inside a single-dose glass tear top vial of Preservative-Free Bupivacaine HCL Injection, USP, 0.5% (5 mg/mL), 30 mL Single-dose (NDC: 0409-1162-02, Lot 38-515-DK, Expiry 1FEB2016). The Bupivacaine HCL Injection has been recalled to user levels that include both human and veterinary.
Currently, Hospira has not received any reports of any consequences associated with the contaminated product. This particular lot was distributed from July 2014 to September 2014.
It is recommended that consumers with any recalled product stop use and distribution. Affected vials of the product should be immediately quarantined. All accounts that a customer may have distributed the product to must be notified at once and all users in their facility who may have come into contact with the product must be informed.
As of right now Hospira will be sending its customers a letter regarding the recall and is arranging for impacted product to be returned to Stericycle.
Risk Factors of Recalled Bupivacaine HCL Injection
Information below provided by the FDA:
- Potential for free floating particulate to be injected into a patient.
- Injected particulate can result in inflammation, low-level allergic or immune response, granuloma formation, and mechanical irritation of tissue.
- Therapy for the issue may be delayed until the particulate is actually observed.