Drug product
Ketorolac Trom 30 mg/mL Injection, packaged in a) 1 mL vials, NDC 61786-0741-01 (Orig: 00548-9021-00), Ref: 33631 and b) 10 x 1 mL vials per tray, NDC 61786-0741-08 (Orig: 00548-9021-00), Ref: 33632, Rx only, Packaged by: RemedyRepack Inc, Indiana, PA 15704; Mfg by: Amphastar, Rancho Cucamonga, CA 91730.
D-1176-2017
Product summary
- Event
- Event 78146
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40 vials
- Official record key
drug-enforcement:D-1176-2017
Official wording
Reason: Crystallization: Product is being recalled due to the manufacturer's recall due to the presence of visible particulate in vials that has been identified as crystalline ketorolac calcium salt.
Code information: Lot #: a) B0158730-060816 (Mfg: XI002A6), Exp: 12/2017 ; and b) B0160669-061516 (Mfg: XI003A6), Exp 12/2017
Distribution pattern: Product was distributed to one consignee in Louisiana.
Derived failure modes
-
Foreign material or chemical contamination
particulate