Ajanta Pharma USA Inc — Class III: Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Aj
Ajanta Pharma USA Inc initiated a Class III recall for Fluphenazine Hydrochloride Tablets, 1mg, due to failed impurities/degradation specifications. Testing at the 18-month long-term stability interval yielded an Out of Specification (OOS) result of 1.1% for Impurity-A, exceeding the 1.0% limit.
This recall affects Ajanta Pharma USA Inc, healthcare providers dispensing the 100-count bottles (NDC 27241-255-01), and quality control personnel responsible for long-term stability monitoring of antipsychotic medications.
A Class III recall indicates that the product defect is unlikely to cause adverse health consequences; however, the failure to meet stability specifications at 18 months suggests a potential issue with the product's degradation profile or manufacturing process. This event highlights the importance of rigorous HPLC monitoring for organic impurities and the potential for shelf-life revisions if degradation patterns are inconsistent with initial filings.
Quality units should review stability data for Fluphenazine Hydrochloride to ensure Impurity-A levels remain within the 1.0 percent specification throughout the shelf life. QA teams may need to assess if existing stability protocols or manufacturing controls require adjustment to mitigate degradation risks identified at the 18-month mark.
Class III. Reason: 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.. 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.. Firm: Ajanta Pharma USA Inc (Bridgewater NJ United States). Status: Ongoing.
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