CEFTRIAXONE for Injection USP recalled over manufacturing violations
- Recall date
- June 1, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Aidarex Pharmaceuticals LLC recalls CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC…
- Recall number
- D-0974-2016
- FDA classification
- Class III
- Brand / firm
- Aidarex Pharmaceuticals LLC
- Sold / distributed
- IN, GA
Why it was recalled
CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01
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