November 25, 2020
Hikma Pharmaceuticals USA Inc. is recalling more than 2 million vials of sodium chloride injection because they failed to meet pH specifications, according to the November 25, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects sodium chloride injection, 0.9%, 0.308 mOsmol/mL, 2-mL single-dose vials (NDC 0641-0497-17) from lots 078338 (Exp. 7/21), 088391 (Exp. 8/21), 098340 (Exp. 9/21), 108325 (Exp. 10/21), and 010018 (Exp. 1/23). Also included in the recall are cartons containing 25 vials (NDC 0641-0497-25) from lot 068322 (Exp. 06/21). The vials were manufactured by West-Ward Pharmaceuticals and distributed throughout the United States.
Hikma Pharmaceuticals voluntarily initiated the recalls on November 3, 2020. On November 20, 2020, the FDA designated them Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Sodium chloride injection is used for diluting or dissolving drugs for intravenous, intramuscular, or subcutaneous injection.