Epidural Injection Recalled

SCA Pharmaceuticals is recalling a single lot of fentanyl 500 mcg/250 mL and bupivacaine HCl 0.1% in 0.9% sodium chloride due to the shipment of rejected units, according to the August 2, 2023, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects 250-mL bags of fentanyl 500 mcg/250 mL and bupivacaine HCl 0.1% in 0.9% sodium chloride injection for epidural use (fentanyl concentration 2 mcg/mL), in single-dose containers (NDC 70004-0253-40), from lot 1223047134 (beyond-use date 9/21/23). Bags from the lot were distributed in Kentucky and New Jersey.

SCA Pharmaceuticals voluntarily initiated the recall July 20, 2023. The FDA designated the recall Class II on July 26, 2023. Products affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Fentanyl and bupivacaine are used to provide anesthesia.