Drug 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.
D-0955-2016
Product summary
- Event
- Event 73830
- Status
- Terminated
- Classification
- Class III
- Quantity
- 741.171 kg
- Official record key
drug-enforcement:D-0955-2016
Official wording
Reason: CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.
Code information: Lot #: B4000935, Exp 01/17; B4005178, Exp 06/17; B4008730, B4008729, B4008727, B4008724, Exp 10/17; B5001647, B5001648, B5001649, Exp 02/18
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Manufacturing or process control
CGMP Deviations