Direct Rx

FDA Regulatory Profile

Summary

Total Recalls
36
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Known Names

direct rx, direct_rx

Recent Recalls

NumberClassProductDate
D-0567-2025Class IIDuloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, DistMarch 7, 2025
D-0568-2025Class IIDuloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-couMarch 7, 2025
D-0364-2025Class IICIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and DistributeJanuary 31, 2025
D-0041-2025Class IIIbuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and DisAugust 9, 2024
D-0508-2023Class IIAlprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NMarch 22, 2023
D-0507-2023Class IIAlprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx DawsonvMarch 22, 2023
D-0509-2023Class IIAlprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx DawsonvilMarch 22, 2023
D-0484-2023Class IISimvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-March 13, 2023
D-0486-2023Class IISimvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90, Packaged and DisMarch 13, 2023
D-0479-2023Class IIRopinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged aMarch 13, 2023
D-0478-2023Class IIRopinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; PackageMarch 13, 2023
D-0485-2023Class IISimvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-March 13, 2023
D-0477-2023Class IIFinasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged March 13, 2023
D-0476-2023Class IIMontelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-March 13, 2023
D-0480-2023Class IIGlimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-March 13, 2023
D-0481-2023Class IIGlimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0488-30; b) 90-March 13, 2023
D-0483-2023Class IISimvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 Packaged aMarch 13, 2023
D-0482-2023Class IIGlimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0250-30; b) 90-March 13, 2023
D-0101-2023Class IIMoxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LLC 9November 2, 2022
D-1535-2022Class IITriamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, DawSeptember 12, 2022