Drug recall D-0864-2020
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.
Reason for recall
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Lots and codes
Lot #: 038366, Exp. Date Mar 2020; 048365, 048367, Exp. Date Apr 2020; 078301, 078303, Exp. Date July 2020; 118358, Exp. Date Nov 2020; 029353, Exp. Date Feb 2021; 019413, Exp. Date Jan 2021
Recall details
- Recalling firm
- Hikma Pharmaceuticals USA Inc., Cherry Hill, NJ
- Quantity
- 101,710 25 vials/shelf-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.