Drug Enforcement D-0568-2025

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Status

Ongoing

Classification

Class II

Report Date

August 13, 2025

Termination Date

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Product Information

Product description
Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-count bottle, NDC 61919-0482-90; Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037,
Product quantity
875 bottles
Reason for recall
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Direct Rx
Address
94 Worldwide Dr, N/A

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

Codes & Dates

Recall number
D-0568-2025
Event ID
97251
Recall initiation date
March 7, 2025
Center classification date
August 4, 2025
Code info
Lot #: a) 15AU2420, 01JY2407, 04OC2411, Exp 01/31/2027; 12SE2418, 24OC2424, 20NO2416, Exp 03/31/2027; 21AU2313, 21JY2311, 05JY2313, Exp Date 01/31/2026 b) 13OC2310, 05SE2304, 04AU2306, 21JY2317, 12JY2306, Exp 01/31/2026; 11JY2416, 28JU2414, 19AU2412, 02AU2409, Exp 01/31/2027; 11SE2416, 24OC2425, Exp 03/31/2027; c) 23AU2317, 21AU2314, Exp 01/31/2026.
More code info
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