CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01
Recall Number: D-0974-2016
Firm: Aidarex Pharmaceuticals LLC
Classification: Class III
Status: Terminated
Report Date: 20160615
Initiation Date: 20160601
Termination Date: 20161014
Reason for Recall
CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.
Product Description
CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01