Hikma Pharmaceuticals USA Inc. recalls Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL Single Dose Vials (NDC 0641-6043-01), 25 v
Recalled January 22, 2020 · FDA recall D-0658-2020 · Hikma Pharmaceuticals USA
Hazard
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS) · FDA Class II
Units
25,817 shelf packs/25 vials per pack
Sold at
Nationwide within the United States
Description
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Product
Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL Single Dose Vials (NDC 0641-6043-01), 25 vials/shelf-pack (NDC 0641-6043-25), For 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 →