US Drug Recall Register
Class III · Low risk Terminated Initiated Jun 1, 2016 (10 years ago)

CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by…

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

Why it was recalled

CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.

What was recalled

CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01

Recalling firm
Aidarex Pharmaceuticals LLC
NDC code
53217-0117-01
Origin
CA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0974-2016

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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