Home / Recalls / Direct Rx / D-0567-2025

D-0567-2025 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
16 bottles

Product Description

Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037, NDC 61919-422-30

Reason for Recall

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

Distribution Pattern

Nationwide

Code Information

Lot #: 02AU2406, Exp 01/31/2027

Other recalls by Direct Rx

  • D-0568-2025 Class II — Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 6191 (March 7, 2025)
  • D-0364-2025 Class II — CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Pac (January 31, 2025)
  • D-0041-2025 Class II — Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 m (August 9, 2024)
  • D-0507-2023 Class II — Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed B (March 22, 2023)
  • D-0508-2023 Class II — Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 6 (March 22, 2023)
  • D-0509-2023 Class II — Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: (March 22, 2023)
  • D-0482-2023 Class II — Glimepiride, USP, 4 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)
  • 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-0483-2023 Class II — Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 6191 (March 13, 2023)