Home / Recalls / Direct Rx / D-0894-2022

D-0894-2022 Class II Terminated

Recalled by Direct Rx — Dawsonville, GA

Recall Details

Product Type
Drugs
Report Date
June 1, 2022
Initiation Date
May 11, 2022
Termination Date
December 2, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6 bottles

Product Description

Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540

Reason for Recall

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .

Distribution Pattern

FL

Code Information

Lots: 19NO2108 Exp. 1/31/25; 19NO2114 Exp. 1/31/25; 22NO2126 Exp. 1/31/25

Other recalls by Direct Rx

  • D-0567-2025 Class II — Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed (March 7, 2025)
  • 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-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)
  • D-0486-2023 Class II — Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431- (March 13, 2023)