Drug Enforcement D-0580-2025

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

Status

Ongoing

Classification

Class II

Report Date

August 20, 2025

Termination Date

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Product Information

Product description
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC 82009-032-10
Product quantity
1,856 bottles
Reason for recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
NJ, AZ, IN

Location & Firm

Recalling firm
Breckenridge Pharmaceutical, Inc.
Address
200 Connell Dr Ste 4200, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0580-2025
Event ID
97336
Recall initiation date
July 25, 2025
Center classification date
August 12, 2025
Code info
Lot 240539C, Exp 1/31/2027
More code info
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