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FDAMarch 11, 2016drug

Ceftriaxone for Injection USP, 250 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-611-01), and b) 10-count Vials per box (NDC 68180-611-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Li...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

lupin pharmaceuticalslupin

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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