Drug 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.
D-0658-2020
Product summary
- Event
- Event 84534
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25,817 shelf packs/25 vials per pack
- Official record key
drug-enforcement:D-0658-2020
Official wording
Reason: Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Code information: 038368, Exp. Mar 2020; 058314, Exp. May 2020; 078305, 078307, Exp. July 2020; 118362 Exp. Nov 2020
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter