Benzodiazepine Injections Recalled

Millions of vials containing generic and branded lorazepam injection are being recalled by Hikma Pharmaceuticals USA Inc after samples failed to meet impurity/degradation specifications. According to the August 17, 2022, US Food and Drug Administration (FDA) Enforcement Report, “out-of-specification results [were] observed for total related compounds during testing.”

The recall affects the following lorazepam products, which were distributed throughout the United States:

• lorazepam injection, 2 mg/mL, 1-mL vial (NDC 0641-6044-01), 25 vials per carton (NDC 0641-6044-25), manufactured by West-Ward Pharmaceuticals, Eatontown, NJ, from lots 060064 (Exp. 6/23), 070084 (Exp. 7/23), 070126 (Exp. 7/23), 080091 (Exp. 8/23), and 080060 (Exp. 8/23);
• Ativan injection (lorazepam), 2 mg/mL, 1-mL vial (NDC 0641-6001-01), 25 vials per carton (NDC 0641-6001-25), manufactured by West-Ward Pharmaceuticals, Eatontown, NJ, from lot 060064Z (Exp. 6/23);
• lorazepam injection, 2 mg/mL, 1-mL vial (NDC 0641-6048-01), 25 vials per carton (NDC 0641-6048-25), Novaplus, manufactured by Hikma, Berkeley Heights, NJ, from lot 070088 (Exp. 7/23); and
• lorazepam injection, 4 mg/mL, 1-mL vial (NDC 0641-6045-01), 25 vials per carton (NDC 0641-6045-25), Novaplus, manufactured by Hikma, Berkeley Heights, NJ, from lot 070096 (Exp. 7/23).

Hikma Pharmaceuticals voluntarily initiated the recall July 11, 2022. On August 5, 2022, the FDA designated the recall Class II. Drugs 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.

Lorazepam is a prescription benzodiazepine with antianxiety, sedative, and anticonvulsant effects. It is indicated for the treatment of status epilepticus and as a preanesthetic.