Quallent Pharmaceuticals recalled 3,591 bottles of Duloxetine Delayed-Release Capsules on August 8, 2025. The recall stems from CGMP deviations regarding an impurity exceeding safety limits. Consumers should stop using the product immediately and contact their healthcare provider.
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
Consumers and healthcare providers should stop using this product immediately. Contact Breckenridge Pharmaceutical, Inc. or your healthcare provider for guidance. Notification method: Letter
The recalled product is Duloxetine Delayed-Release Capsules, USP, 30 mg, with 1,000 capsules per bottle. Manufactured by Towa Pharmaceutical Europe, S.L., it is distributed in Arizona, Indiana, and New Jersey. The NDC is 82009-030-10, and the lot number is 240927C, expiring on April 30, 2027.
The recall addresses CGMP deviations, specifically the presence of N-nitroso-duloxetine impurity above the proposed interim limit. This impurity poses significant health risks, leading to a high hazard classification.
No specific incidents or injuries have been reported related to this recall. The impurity issue presents potential health risks, but actual harm to consumers remains unreported.
Stop using the recalled Duloxetine Capsules immediately. Contact Breckenridge Pharmaceutical, Inc. or your healthcare provider for further guidance and potential medication alternatives.
For more information, consumers can reach Breckenridge Pharmaceutical, Inc. through their official website or customer service line. Further details can also be found on the FDA's enforcement report page.
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