FDA-Drug2016-06-15Class III
CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01
Aidarex Pharmaceuticals LLC
Hazard
CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.
Sold states
IN, GA
Affected count
10
Manufactured in
595 N Smith Ave Ste B, N/A, Corona, CA, United States
Products
CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0974-2016Don't want to check this manually?
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