November 20, 2020
Baxter Healthcare Corporation is recalling three lots of bupivacaine hydrochloride injection because black and transparent particles were visible in the solution, according to the November 18, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects bupivacaine hydrochloride in 8.25% dextrose injection, spinal 0.75% (15 mg/2 mL), 10 x 2-mL single-dose ampules (NDC 36000-092-10) from lots A0B1241 (Exp. 10/20), A0C0091 (Exp. 12/20), and A0D0268 (Exp. 2/22). The injections were distributed throughout the United States.
Baxter Healthcare Corporation voluntarily initiated the recalls on October 7, 2020. The FDA designated them Class II on November 12, 2020, signaling use of the recalled injections could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Bupivacaine hydrochloride in 8.25% dextrose injection is indicated for the production of a subarachnoid block, or spinal anesthesia.