Ajanta Pharma Ltd. — Class II: Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b)
Ajanta Pharma Ltd. is conducting a Class II recall of Duloxetine Delayed-Release Capsules (30 mg) due to CGMP deviations involving N-nitroso-Duloxetine impurity levels exceeding the FDA recommended limit of 0.83 ppm. The issue was identified during 12-month and 18-month long-term stability testing intervals.
The recall affects Ajanta Pharma Ltd., its US distributor Ajanta Pharma USA Inc., and entities involved in the distribution or dispensing of specific NDCs (27241-098-09, 27241-098-03, 27241-098-10) of 30 mg Duloxetine Delayed-Release Capsules.
This recall underscores the regulatory importance of long-term stability monitoring and the management of nitrosamine impurities in finished dosage forms. The Class II designation suggests that while the exposure risk is not immediate, the presence of impurities above recommended thresholds constitutes a significant CGMP failure. Regulatory departments may interpret this as a signal to prioritize nitrosamine risk assessments for related product portfolios.
QA and batch release teams should review stability testing protocols for nitroamine impurities in duloxetine products. Regulatory teams should monitor ongoing stability intervals (specifically 12-month and 18-month marks) for any trends exceeding established limits. Ensure NDC-specific inventory is identified and quarantined if subject to this ongoing recall.
Class II. Reason: CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.. Product: Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India. Firm: Ajanta Pharma Ltd. (Aurangabad India). Status: Ongoing.
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