Ajanta Pharma USA Inc: Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Ajanta Pharma USA Inc
- 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.
- Reason / hazard
- 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
- Status
- Ongoing
- Distribution / sold at
- Nationwide within the U.S
- Recall initiated
- 2026-08-25
- Code info
- Lot #: DJ23254, Exp. Date 11/30/2026; DJ10205, Exp. Date 04/30/2027.
- Product quantity
- 403,200 tablets
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Bridgewater
- State
- NJ
- Country
- United States
- Event id
- 99733
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