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 for recall: CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.
Recall initiated: 20160311
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated