FDA recall D-0974-2016

Aidarex Pharmaceuticals LLC · Class III · drug

Product

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

Reason for recall

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

Distribution

IN, GA

Key facts

Status
Terminated
Initiation date
2016-06-01
Report date
2016-06-15
Termination date
2016-10-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Corona, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0974-2016