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.
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.
Consumers and healthcare providers should stop using this product immediately. Contact Ajanta Pharma Ltd. or your healthcare provider for guidance. Notification method: Letter
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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. Generic: DULOXETINE; Brand: DULOXETINE. 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.. Classification: Class II. Quantity: 312,894 packs. Distribution: Nationwide within U.S
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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.
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.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Breckenridge Pharmaceutical, Inc. recalled 7,389 bottles of Duloxetine Delayed-Release Capsules on November 24, 2025. The recall stems from CGMP deviations and the presence of N-nitroso-duloxetine impurity above FDA limits. Consumers should stop using the product immediately and contact healthcare providers for guidance.
Towa Pharmaceuticals recalled 3,397 bottles of Duloxetine Delayed-Release Capsules on November 24, 2025. The recall stems from CGMP deviations resulting in N-nitroso-duloxetine levels exceeding FDA limits. Consumers must stop using the product immediately.
Breckenridge Pharmaceutical recalls duloxetine delayed-release capsules due to CGMP deviations raising N-nitroso-duloxetine impurity above interim limit. The bottles were distributed to Arizona, Indiana and New Jersey. Consumers should stop using the product and contact their healthcare provider for guidance.
Quallent Pharmaceuticals Health LLC recalls 1,856 bottles of Duloxetine delayed-release capsules due to CGMP deviations and an impurity above FDA interim limits. The recall is active as of August 20, 2025. Patients and providers should stop use and contact Breckenridge Pharmaceutical or a healthcare provider for guidance.