Direct Rx Recalls
37 recalls on record · October 7, 2020 to July 1, 2026 · Drugs
Recalls by year
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26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 29, 2021DrugsFDA
Direct Rx recalls Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Glen
Hazard: CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
March 24, 2021DrugsFDA
Direct Rx recalls Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonv
Hazard: cGMP deviations: The quantity of active ingredient used for the product lot was inadvertently taken from an ingredient lot from an alternate supplier before that specific lot was formally qualified for use by the manufacturing site.
November 11, 2020DrugsFDA
Direct Rx recalls Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90
Hazard: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
October 14, 2020DrugsFDA
Direct Rx recalls Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC
Hazard: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level per manufacturer
October 14, 2020DrugsFDA
Direct Rx recalls Ranitidine 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-455
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
October 14, 2020DrugsFDA
Direct Rx recalls Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-339-90) bottles, Rx only, Packaged and Distr
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
October 7, 2020DrugsFDA
Direct Rx recalls Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Torrent Pharm
Hazard: CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.