FDA Recall D-0482-2024

Breckenridge Pharmaceutical, Inc · Berlin, CT

Class II Ongoing 745 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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.

Lot / code: 220265: Exp. Feb 2025 220088: Exp. Nov 2024 220267: Exp. Feb 2025 220256: Exp. Feb 2025 220225: Exp. Jan 2025 220269: Exp. Feb 2025

Quantity: 281,554/90 & 1000 count bottles

Reason for recall

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

Recall record

Recall number: D-0482-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US Nationwide.
Recall initiated: 2024-04-29
Classified by FDA Center: 2024-05-04
FDA published: 2024-05-15
Recalling firm: Breckenridge Pharmaceutical, Inc
Firm location: Berlin, CT

Drug identification

Brand name(s): DULOXETINE
Generic name(s): DULOXETINE HYDROCHLORIDE
Manufacturer(s): Breckenridge Pharmaceutical, Inc.
NDC(s): 51991-746, 51991-747, 51991-748, 51991-750
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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