D-0955-2016 Class III Terminated
FDA drug recall D-0955-2016 was initiated by Lupin Pharmaceuticals Inc. on Mar 11, 2016 and is designated Class III. Reason for recall: CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications. The recall status is terminated (terminated Aug 14, 2017). Affected quantity: 741.171 kg.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 8, 2016
- Initiation Date
- Mar 11, 2016
- Termination Date
- Aug 14, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 741.171 kg
Product Description
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 for Recall
CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot #: B4000935, Exp 01/17; B4005178, Exp 06/17; B4008730, B4008729, B4008727, B4008724, Exp 10/17; B5001647, B5001648, B5001649, Exp 02/18
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0955-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026