FDA Drug recall D-0974-2016
CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01
- FDA Drug
- Class III
- terminated
- Published 2016-06-15
On 2016-06-15 the FDA classified a Class III recall of CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01 by Aidarex Pharmaceuticals, citing CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0974-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-06-01 |
| Published | 2016-06-15 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Aidarex Pharmaceuticals |
| Distribution | GA, IN |
Product
CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01
Reason
CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.
Identifiers
| code_info | Lot#: 47312-1, Exp 01/2018 |
|---|
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-0974-2016%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.