Lupin Pharmaceuticals Inc. recalls Ceftriaxone for Injection USP, 250 mg, packaged in a) one Single Use Vial (NDC 68180-611-01) and b) 10 Single Use Vials…

Recall date

December 20, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0355-2019

FDA classification

Class I

Brand / firm

Lupin Pharmaceuticals Inc.

Sold / distributed

Nationwide in the USA and Puerto Rico.

Why it was recalled

Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Ceftriaxone for Injection USP, 250 mg, packaged in a) one Single Use Vial (NDC 68180-611-01) and b) 10 Single Use Vials per box (NDC 68180-611-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.