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FDARecalled Sep 16, 2026 · #D-0836-2026

Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-255-01.

Hazard

Class III — low health risk

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Description

Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent. Classification: Class III Distribution: Nationwide within the U.S

Product details

Product
Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-255-01.
Type
Drugs
Manufacturer
Ajanta Pharma USA Inc
Model numbers
DJ23254
UPCs
—