Duloxetine Delayed-Release Capsules Recalled for N-Nitroso Impurity Above Safe Levels
Rising Pharma is recalling Duloxetine Delayed-Release Capsules 30 mg (Lot DTB23111A) distributed nationwide due to N-nitroso-duloxetine impurity above the FDA's recommended interim limit. This manufacturing impurity resulted from a CGMP deviation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves the presence of an impurity (N-nitroso-duloxetine) that exceeds FDA-recommended interim limits due to a manufacturing deviation. Although no illnesses have been reported, N-nitroso compounds are recognized as potential hazards, meeting the criteria for a risk-of-harm situation without yet-reported injury.
Plain-English summary
Rising Pharma Holding, Inc. is recalling Duloxetine Delayed-Release Capsules, USP, 30 mg in 1,000-count bottles distributed nationwide in the United States. The affected lot number is DTB23111A with an expiration date of 8/31/2025 (NDC 57237-018-99). Approximately 1,223 bottles have been distributed.
The recall was initiated due to the presence of N-nitroso-duloxetine impurity above the FDA's recommended interim limit. This impurity resulted from a manufacturing deviation in current Good Manufacturing Practice (CGMP) compliance during production.
This recall affects patients who received the affected lot of duloxetine from distributors nationwide. Patients taking this medication should consult their healthcare provider regarding this recall and for guidance on continuing their duloxetine therapy. Healthcare facilities and pharmacies should identify, quarantine, and return any remaining units of Lot DTB23111A to the distributor.
The recalled product
- Product
- Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99
- Manufacturer
- Rising Pharma Holding, Inc.
- Category
- Drug
- Hazard
- n-nitroso-impurity
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: DTB23111A
- Exp 8/31/2025
Distribution
Distributed nationwide across the United States.
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