FDA Drug recall D-1354-2022
Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron Pharmaceutical Corporatio…
- FDA Drug
- Class II
- terminated
- Published 2022-08-24
On 2022-08-24 the FDA classified a Class II recall of Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron Pharmaceutical Corporatio… by Nephron Sc, citing cGMP Deviations: deviations leading to potential cross-contamination.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1354-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-08-10 |
| Published | 2022-08-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Nephron Sc |
| Distribution | US |
Product
Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron Pharmaceutical Corporation 4500 12th Street Extension West Columbia, SV 29172, NDC 0487-6232-01
Reason
cGMP Deviations: deviations leading to potential cross-contamination.
Identifiers
| ndc | 0487-6232-01 |
|---|---|
| code_info | Lot#: 023011 Exp 8/31/2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1354-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.