FDA Drug recall D-1176-2017
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 pe…
- FDA Drug
- Class II
- terminated
- Published 2017-10-04
On 2017-10-04 the FDA classified a Class II recall of 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 pe… by Remedyrepack, citing 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 c….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1176-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-22 |
| Published | 2017-10-04 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Remedyrepack |
| Distribution | LA |
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.
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.
Identifiers
| code_info | Lot #: a) B0158730-060816 (Mfg: XI002A6), Exp: 12/2017 ; and b) B0160669-061516 (Mfg: XI003A6), Exp 12/2017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1176-2017%22
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