FDA recall D-0955-2016

Product

Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep-462 046, (Madhya Pradesh) India; Regd. Office: 159, CST Road Kalina, Santacruz (E), Mumbai- 400 098, (Maharashtra) India.

Reason for recall

CGMP Deviations: active pharmaceutical ingredient 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-0955-2016