Drug product
Ketorolac Trom, 30 mg/1mL Inj. for I.V./I.M. Use, Rx Only, QTY: 1 ml, Repackaged by: RemedyRepack Inc., Indiana, PA 15701 NDC 70518-1239-00
D-0867-2020
Product summary
- Event
- Event 84900
- Status
- Terminated
- Classification
- Class I
- Quantity
- 75 1 ml vials
- Official record key
drug-enforcement:D-0867-2020
Official wording
Reason: Presence of Particulate Matter: Medication relabeled at facility was recalled by the manufacturer due to small black particles noticed during routine visual inspection. of retain samples.
Code information: Lot # B0444562-060118, exp. 04/2020, B0537002-112118, exp 07/2020
Distribution pattern: Product distributed in OK and LA.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter