FDA Drug recall D-1274-2019
Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL…
- FDA Drug
- Class II
- terminated
- Published 2019-05-15
On 2019-05-15 the FDA classified a Class II recall of Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL… by Sagent Pharmaceuticals, citing lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1274-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-04-30 |
| Published | 2019-05-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sagent Pharmaceuticals |
| Distribution | US |
Product
Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, NDC: 25021-701-02
Reason
Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.
Identifiers
| ndc | 25021-700-01 |
|---|---|
| ndc | 25021-701-01 |
| ndc | 25021-701-02 |
| code_info | Lot #: M813513, Exp. Feb 2020 |
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-1274-2019%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.