Ketorolac Tromethamine Injection — Class II drug recall D-1274-2019
Terminated recall by Sagent Pharmaceuticals Inc, reported 2019-05-15, distributed nationwide. Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing proces
| Recall number | D-1274-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sagent Pharmaceuticals Inc, Schaumburg, IL, United States |
| Recall initiated | 2019-04-30 |
| Classified | 2019-05-09 |
| Reported by FDA | 2019-05-15 |
| Terminated | 2020-09-28 |
| Distributed | Nationwide (US) |
| Quantity | 75,825 vials |
| Reason classes | microbial contamination, sterility |
| NDC | 25021-0700, 25021-0700-01, 25021-0701, 25021-0701-01, 25021-0701-02 |
| Lot numbers | M813513 |
| Expiration dates | 2020-02-20 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1274-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.