FDAFDA · Food and drugs·Recall number D-0974-2016
CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01
Published June 15, 2016 · Recall initiated: June 1, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.
What to do
Voluntary: Firm initiated · FAX
Recall details
- Manufacturer
- Aidarex Pharmaceuticals LLC
- Distributor
- IN, GA
- Lot
- Lot#: 47312-1, Exp 01/2018
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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