Duloxetine Delayed-Release Capsules recalled nationwide for nitrosamine impurity
Duloxetine Delayed-Release Capsules USP 20 mg are being recalled nationwide due to presence of nitrosamine impurity above FDA acceptable limits. No adverse events 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: FDA Class II recall involving a risk-of-harm product (nitrosamine impurity above acceptable limits). No illnesses or injuries have been reported, making the hazard theoretical rather than confirmed, which limits the score to High per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories is recalling Duloxetine Delayed-Release Capsules USP, 20 mg, distributed nationwide. Two packaging configurations are affected: 30-unit-dose blister packs (NDC 0904-7043-04, lot N01530) and 100-unit-dose blister packs (NDC 0904-7043-61, lot N01540), both with expiration dates of January 2025.
The recall stems from manufacturing deviations detected during quality control testing. Testing found that the affected lots contain Nitrosamine Drug Substances Related Impurity (N-Nitroso-Duloxetine) at levels above the FDA's recommended acceptable intake limit.
No illnesses or adverse events have been reported in connection with these lots. Patients currently taking affected batches should consult with their healthcare provider or pharmacist before making any changes to their medication regimen. Healthcare providers and pharmacists should verify whether their supplies contain the affected lot numbers.
The recalled product
- Product
- Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA.
- Manufacturer
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Category
- Drug
- Hazard
- nitrosamine-impurity
- manufacturing-deviation
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 #: a) N01530
- Exp. Date 01/2025
- b) N01540
- Exp. Date. 01/2025
Distribution
Distributed nationwide across the United States.
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