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Diluent Recall Grows


December 23, 2020

Hikma Pharmaceuticals USA Inc. is expanding its recall of sodium chloride injection announced last month to include an additional 1.3 million vials. The firm cited product failure to meet pH specifications.  

The most recent recall, included in the December 23, 2020, US Food and Drug Administration (FDA) Enforcement Report, affects sodium chloride injection, 0.9%, 0.308 mOsmol/mL, 2-mL single-dose vials (NDC 0641-0497-17) from lots 048315 (Exp. 4/21), 068320 (Exp. 6/21), 128302 (Exp. 12/21), and 099349 (Exp. 9/22). The product was manufactured by West-Ward Pharmaceuticals and distributed throughout the United States. 

Hikma Pharmaceuticals voluntarily initiated the new recalls December 7, 2020. On December 16, 2020, the FDA designated them 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.

Sodium chloride injection is used for diluting or dissolving drugs for intravenous, intramuscular, or subcutaneous injection.

Jolynn Tumolo

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