Duloxetine Delayed-Release Capsules Recalled for Manufacturing Impurity Above Safe Limits
Rising Pharma is recalling 73,680 bottles of Duloxetine 20 mg capsules nationwide due to N-nitroso-duloxetine impurity above recommended limits from manufacturing deviations. No illnesses have been reported.
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 is an FDA Class II pharmaceutical recall due to chemical impurity (N-nitroso-duloxetine) above recommended interim limits from manufacturing deviations. No illnesses, hospitalizations, or adverse events have been reported, placing it in the High category for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Rising Pharma Holding, Inc. is recalling Duloxetine Delayed-Release Capsules USP 20 mg in 60-count bottles distributed nationwide. Approximately 73,680 bottles are affected, including lot numbers DT2023003A, DT2023007A, and DT2023008A with expiration dates in January 2025. The product bears NDC 57237-017-60.
The recall addresses Current Good Manufacturing Practice (CGMP) deviations that resulted in N-nitroso-duloxetine impurity above FDA's recommended interim limits. N-nitroso compounds are a class of impurities of regulatory concern in pharmaceutical manufacturing.
Patients with a bottle of this medication should check the lot number on the label. If the lot number matches one of the recalled lots, contact your healthcare provider or pharmacist. Rising Pharma Holding, Inc., is based in East Brunswick, New Jersey.
As of the recall announcement, no illnesses or adverse health effects have been reported.
The recalled product
- Product
- Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
- Manufacturer
- Rising Pharma Holding, Inc.
- Category
- Drug
- Hazard
- chemical-impurity
- manufacturing-defect
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 (4)
- Lot # DT2023003A
- DT2023007A
- DT2023008A
- exp. date Jan-25
Distribution
Distributed nationwide across the United States.
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