Hikma Pharmaceuticals USA Inc. recalls Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01), 25 vials/shelf-pa
Recalled January 22, 2020 · FDA recall D-0864-2020 · Hikma Pharmaceuticals USA
Hazard
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS) · FDA Class I
Units
101,710 25 vials/shelf-pack
Sold at
Nationwide within the United States
Description
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Product
Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01), 25 vials/shelf-pack (NDC 0641-6042-25), For IV or IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, NJ 07724 USA.
Manufacturer(s)
Hikma Pharmaceuticals USA Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →