Class III
Terminated
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.
This recall has been terminated (originally issued June 8, 2016).
- Company
- Lupin Pharmaceuticals Inc.
- Recall Initiated
- March 11, 2016
- Posted
- June 8, 2016
- Recall Number
- D-0955-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 741.171 kg
- Firm Location
- Baltimore, MD, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lot #: B4000935, Exp 01/17; B4005178, Exp 06/17; B4008730, B4008729, B4008727, B4008724, Exp 10/17; B5001647, B5001648, B5001649, Exp 02/18
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