Product: Ceftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-622-01), and b) 10-count Vials per box (NDC 68180-622-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.
Reason for recall: CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Recall initiated: 20160311
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated