More Than 300,000 Anesthetic Injections Recalled Over Mix-Up

A label mix-up has prompted Pfizer Inc to recall more than 300,000 vials of the anesthetics lidocaine and bupivacaine, according to the June 9, 2021, US Food and Drug Administration (FDA) Enforcement Report. 

“Some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP, may contain 1% Lidocaine HCl Injection, USP,” the report explained, “and some vials labeled to contain 1% Lidocaine HCl Injection, USP, may contain 0.5% Bupivacaine Hydrochloride Injection, USP.”

The recall includes the following products, which were distributed by Hospira Inc. in the United States, Puerto Rico, and Guam:

• 1% lidocaine hydrochloride injection, 300 mg/30 mL (10 mg/mL), 30-mL single-dose vials (NDC 0409-4279-16), 25 per carton (NDC 0409-4279-02), from lot EG8933 (Exp. 8/1/22); and
• 0.5% bupivacaine hydrochloride injection, 150 mg/30 mL (5 mg/mL), 30-mL single-dose teartop vials (NDC 0409-1162-19), 25 per carton (NDC 0406-1162-02), from lot EG6023 (Exp. 7/1/22).

Pfizer initiated the recalls May 3, 2021. The FDA has yet to issue a recall classification. 

Both lidocaine and bupivacaine are prescription anesthetic agents.