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.
Recall initiated: 20160601
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated