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Direct Rx

Recalls

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
20205
20212
202210
202315
20241
20253
20261
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FDA Recall Terminated Historical recordClass II

Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0250-30; b) 90-count bottle, NDC 61919-0250-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

by Direct Rx

Reason
cGMP deviations
Published
April 5, 2023
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0488-30; b) 90-count bottle, NDC 61919-0448-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

by Direct Rx

Reason
cGMP deviations
Published
April 5, 2023
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC 61919-0723-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

by Direct Rx

Reason
cGMP deviations
Published
April 5, 2023
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

by Direct Rx

Reason
cGMP deviations
Published
April 5, 2023
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

by Direct Rx

Reason
cGMP deviations
Published
April 5, 2023
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By: Direct Rx

by Direct Rx

Reason
cGMP deviations
Published
April 5, 2023
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 61919-0009-90; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

by Direct Rx

Reason
cGMP deviations
Published
April 5, 2023
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LLC 94 Worldwide Drive, Dawsonville, GA 30534, NDC 72189-0334-05

by Direct Rx

Reason
cGMP deviation: discontinue of stability support for product.
Published
January 18, 2023
Distribution
FL

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FDA Recall Completed Historical recordClass II

Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534, Dist. By Perrigo, Allegan, MI 49010, NDC 72189-330-80.

by Direct Rx

Reason
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Published
September 21, 2022
Distribution
Physicians and Medical Facilities in GA…

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FDA Recall Terminated Historical recordClass II

Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 a) 30 Tabs NDC 72189-167-30; b) 90 Tabs NDC 72189-167-90

by Direct Rx

Reason
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Published
June 8, 2022
Distribution
Multiple states

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FDA Recall Terminated Historical recordClass II

Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540

by Direct Rx

Reason
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Published
June 1, 2022
Distribution
FL

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FDA Recall Terminated Historical recordClass II

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

by Direct Rx

Reason
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Published
June 1, 2022
Distribution
FL

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This page lists recalls that name Direct Rx as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.