Duloxetine 30mg delayed-release capsules exceed nitrosamine impurity interim limit
Duloxetine Delayed-Release Capsules, USP, 30 mg, in 1,000-capsule bottles are being recalled because of N-nitroso-duloxetine impurity above the FDA recommended interim limit.
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 where a nitrosamine impurity exceeds the FDA interim limit, a risk of harm with no injuries reported in the source.
Plain-English summary
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-capsule bottles, prescription only, manufactured by Towa Pharmaceutical Europe, S.L. of Martorelles, Barcelona, Spain and distributed by Breckenridge Pharmaceuticals, Inc. of Berkeley Heights, New Jersey, are being recalled. The action covers 14,729 bottles.
The stated reason is CGMP deviations: the presence of N-nitroso-duloxetine impurity above the FDA recommended interim limit. The FDA classified the action as Class II.
The affected lot is 241180C, expiring April 2027. Distribution was nationwide within the United States.
Patients should not stop taking a prescribed medicine without advice. Anyone holding the affected lot should speak to their pharmacist or prescriber and follow the instructions issued by the firm.
The recalled product
- Product
- DULOXETINE (DULOXETINE HYDROCHLORIDE)
- Brand
- DULOXETINE
- Manufacturer
- Breckenridge Pharmaceutical, Inc.
- Category
- Drug — Antidepressant capsule
- Affected units
- 14,729
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: 241180C
- Exp. Date April 2027.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Breckenridge Pharmaceutical, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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