Drug 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.
D-0864-2020
Product summary
- Event
- Event 84534
- Status
- Terminated
- Classification
- Class I
- Quantity
- 101,710 25 vials/shelf-pack
- Official record key
drug-enforcement:D-0864-2020
Official wording
Reason: Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Code information: 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
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter