Home / Recalls / Direct Rx / D-0484-2023

D-0484-2023 Class II Terminated

Recalled by Direct Rx — Dawsonville, GA

Recall Details

Product Type
Drugs
Report Date
April 5, 2023
Initiation Date
March 13, 2023
Termination Date
June 17, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
30 count: 6 bottles; 90 count: 106 bottles

Product Description

Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle, NDC61919-0688-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Reason for Recall

cGMP deviations

Distribution Pattern

Nationwide in the USA

Code Information

a) [30-count bottles] Lot, expiry: 05AU2206, exp 10/31/23; b) [90-count bottles] Lot, expiry: 30MA2213, exp 6/30/23; 10DE2124, exp 3/31/23; 15MA2224, exp 5/32/23; 27JA2229, exp 3/31/23.

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  • 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-0483-2023 Class II — Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 6191 (March 13, 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-0481-2023 Class II — Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 6 (March 13, 2023)