FDA Drug recall D-0955-2016
Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931
- FDA Drug
- Class III
- terminated
- Published 2016-06-08
On 2016-06-08 the FDA classified a Class III recall of Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931 by Lupin Pharmaceuticals, citing CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0955-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-03-11 |
| Published | 2016-06-08 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
Product
Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep-462 046, (Madhya Pradesh) India; Regd. Office: 159, CST Road Kalina, Santacruz (E), Mumbai- 400 098, (Maharashtra) India.
Reason
CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.
Identifiers
| code_info | Lot #: B4000935, Exp 01/17; B4005178, Exp 06/17; B4008730, B4008729, B4008727, B4008724, Exp 10/17; B5001647, B5001648, B5001649, Exp 02/18 |
|---|
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-0955-2016%22
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