FDA recall D-0953-2016

Product

Ceftriaxone for Injection USP, 1 g, Single Use Vial (NDC 68180-633-01) packaged in 10-count Vials per box (NDC 68180-633-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-633-01.

Reason for recall

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

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2016-03-11

Report date

2016-06-08

Termination date

2017-08-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0953-2016