US Drug Recall Register
Class III · Low risk Terminated Initiated Mar 11, 2016 (10 years ago)

Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.

What was recalled

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.

Recalling firm
Lupin Pharmaceuticals Inc.
Origin
MD, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0955-2016

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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