Duloxetine capsules recalled over N-nitroso-duloxetine above the FDA recommended limit
Breckenridge Pharmaceutical is recalling 3,397 bottles of Duloxetine Delayed-Release Capsules, 60 mg, over the presence of N-nitroso-duloxetine above the FDA recommended 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: Scored 3 under the risk-of-harm criterion: an impurity present above the FDA recommended limit is a stated product defect, and no injuries are reported.
Plain-English summary
Duloxetine Delayed-Release Capsules, USP, 60 mg, in 1000-capsule bottles, are being recalled. The prescription product is manufactured by Towa Pharmaceuticals Europe, S.L. in Marotrelles, Barcelona, Spain, for Quallient Pharmaceuticals Health, LLC of Grand Cayman, Cayman Islands.
The recall follows current good manufacturing practice deviations and the presence of N-nitroso-duloxetine impurity above the FDA recommended limit.
The recall covers 3,397 bottles from lots 240947C and 240962C, both with an expiry date of 04/2027. Distribution was nationwide within the United States. The FDA has classified the action as Class II.
Patients should not stop taking a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific bottle is affected and arrange a replacement.
The recalled product
- Product
- Urinary Tract Infection Test
- Manufacturer
- GET TESTED INTERNATIONAL AB
- Category
- Drug — Antidepressant
- Affected units
- 40
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)
- EAN: 7340221700529
- SKU: A-URI
- UDI-DI: None
- Lot/Serial Number: All Lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 92 recalled by GET TESTED INTERNATIONAL AB under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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