Duloxetine delayed-release capsules recalled over N-nitroso-duloxetine above interim limit
Duloxetine Delayed-Release Capsules, USP, 30 mg, lot 240927C, made for Quallent Pharmaceuticals, are recalled because N-nitroso-duloxetine was above the proposed interim limit. 3,591 bottles are affected.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; a nitrosamine above the proposed interim limit is a potential harm and no injuries are reported.
Plain-English summary
Duloxetine Delayed-Release Capsules, USP, 30 mg, in 1,000-capsule bottles and available on prescription only, manufactured by Towa Pharmaceutical Europe, S.L. in Martorelles, Spain for Quallent Pharmaceuticals Health LLC, are being recalled. The affected product is lot 240927C with an expiry of 04/30/2027, and the recall covers 3,591 bottles distributed in Arizona, Indiana and New Jersey.
The recall follows current good manufacturing practice deviations: the N-nitroso-duloxetine impurity was above the proposed interim limit. The FDA classified the action as Class II.
Patients should check the lot number on their bottle against the recall and should not stop taking a prescribed medicine without speaking to their pharmacist or prescriber about a replacement supply.
The recalled product
- Product
- DULOXETINE (DULOXETINE HYDROCHLORIDE)
- Brand
- DULOXETINE
- Manufacturer
- Breckenridge Pharmaceutical, Inc.
- Category
- Drug — Central Nervous System
- Hazard
- nitrosamine-impurity
- cgmp-deviation
- prescription-drug
- class-ii
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 240927C
- Exp 04/30/2027
Distribution
Distributed in 3 states:
- AZ
- IN
- NJ
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