Drug Enforcement D-0482-2024

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

Status

Ongoing

Classification

Class II

Report Date

May 15, 2024

Termination Date

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Product Information

Product description
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
Product quantity
281,554/90 & 1000 count 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
US Nationwide.

Location & Firm

Recalling firm
Breckenridge Pharmaceutical, Inc
Address
15 Massirio Dr Ste 201, N/A

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

Codes & Dates

Recall number
D-0482-2024
Event ID
94483
Recall initiation date
April 29, 2024
Center classification date
May 4, 2024
Code info
220265: Exp. Feb 2025 220088: Exp. Nov 2024 220267: Exp. Feb 2025 220256: Exp. Feb 2025 220225: Exp. Jan 2025 220269: Exp. Feb 2025
More code info
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