Ajanta Pharma USA recalls Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only…
FDAHome & Health recallNo official product photo was published for this recall.
What should I do?
Check your medicine against the product and lot details below. If it matches, stop using it, contact your pharmacist or doctor, and return it as directed.
What's the 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.
What's affected
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.
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