Duloxetine 60mg Capsule Recall Due to Manufacturing Impurity
Breckenridge Pharmaceutical recalls 11,100 bottles of Duloxetine 60mg capsules distributed nationwide due to the presence of N-nitroso-duloxetine impurity exceeding FDA recommended interim limits from manufacturing deviations.
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 with no reported illnesses or injuries. The product contains an impurity exceeding the FDA's recommended interim limit, constituting a manufacturing defect and potential risk-of-harm product. Per the severity rubric, risk-of-harm products without reported injury score 3 (High).
Plain-English summary
Breckenridge Pharmaceutical, Inc. is recalling Duloxetine Delayed-Release Capsules, USP, 60mg (Lot 240301C, expiration 01/2027). The recall affects approximately 11,100 bottles distributed nationwide.
The recall was initiated due to CGMP (Current Good Manufacturing Practices) deviations during manufacturing. The affected product contains N-nitroso-duloxetine impurity at levels exceeding the FDA's recommended interim limit.
Patients who have received this medication should consult their healthcare provider or pharmacist regarding the recall. Healthcare providers and patients with questions about this recall should contact Breckenridge Pharmaceutical, Inc., at Berkeley Heights, New Jersey, or the FDA.
The recalled product
- Product
- DULOXETINE (DULOXETINE HYDROCHLORIDE)
- Brand
- DULOXETINE
- Manufacturer
- Breckenridge Pharmaceutical, Inc.
- Hazard
- n-nitroso-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 (2)
- Lot#: 240301C
- Expiration: 01/2027.
Distribution
Distributed nationwide across the United States.
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