CEFTRIAXONE for Injection USP — Class III drug recall D-0974-2016
Terminated recall by Aidarex Pharmaceuticals LLC, reported 2016-06-15, distributed in GA, IN. CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final
| Recall number | D-0974-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aidarex Pharmaceuticals LLC, Corona, CA, United States |
| Recall initiated | 2016-06-01 |
| Classified | 2016-06-07 |
| Reported by FDA | 2016-06-15 |
| Terminated | 2016-10-14 |
| Distributed | GA, IN |
| Quantity | 10 |
| Reason classes | cgmp, specification failure |
| NDC | 53217-0117-01 |
| Lot numbers | 47312-1 |
| Expiration dates | 2018-01 |
Product
CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01
Reason for recall
CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.
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-0974-2016. 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.