RemedyRepack Inc. recalls Ketorolac Trom 30 mg/mL Injection, packaged in a) 1 mL vials, NDC 61786-0741-01 (Orig: 00548-9021-00), Ref: 33631 and b)
Recalled October 4, 2017 · FDA recall D-1176-2017 · RemedyRepack
Hazard
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. · FDA Class II
Units
40 vials
Sold at
Product was distributed to one consignee in Louisiana.
Description
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.
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.
Manufacturer(s)
RemedyRepack Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →