Home / Recalls / Direct Rx / D-0568-2025

D-0568-2025 Class II Ongoing

Recalled by Direct Rx — Dawsonville, GA

Recall Details

Product Type
Drugs
Report Date
August 13, 2025
Initiation Date
March 7, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
875 bottles

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,

Reason for Recall

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

Distribution Pattern

Nationwide

Code Information

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.

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  • D-0507-2023 Class II — Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed B (March 22, 2023)
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  • D-0483-2023 Class II — Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 6191 (March 13, 2023)
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  • D-0481-2023 Class II — Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 6 (March 13, 2023)
  • D-0477-2023 Class II — Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 6191 (March 13, 2023)