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

Ceftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-count Vials per…

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

Why it was recalled

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

What was recalled

Ceftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-622-01), and b) 10-count Vials per box (NDC 68180-622-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.

Recalling firm
Lupin Pharmaceuticals Inc.
NDC code
68180-622-01
Origin
MD, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0952-2016

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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