Drug recall D-0658-2020
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.
Reason for recall
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Lots and codes
038368, Exp. Mar 2020; 058314, Exp. May 2020; 078305, 078307, Exp. July 2020; 118362 Exp. Nov 2020
Recall details
- Recalling firm
- Hikma Pharmaceuticals USA Inc., Cherry Hill, NJ
- Quantity
- 25,817 shelf packs/25 vials per pack
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 17, 2019
- Terminated
- June 9, 2021
Related products
- Ketorolac Tromethamine – drug information
- NDC 0641-6043 Ketorolac Tromethamine · Ketorolac Tromethamine 30 mg/mL · Hikma Pharmaceuticals USA Inc.
- NDC 0641-6042 Ketorolac Tromethamine · Ketorolac Tromethamine 30 mg/mL · Hikma Pharmaceuticals USA Inc.
- NDC 0641-6041 Ketorolac Tromethamine · Ketorolac Tromethamine 15 mg/mL · Hikma Pharmaceuticals USA Inc.