FDA issues warning to Dollar Tree about selling 'potentially unsafe drugs'

The US Food and Drug Administration has issued a...

Posted: Nov 15, 2019 8:53 AM

The US Food and Drug Administration has issued a warning letter to Dollar Tree for receiving over-the-counter drugs produced by foreign manufacturers that have been found to be adulterated, including acne treatment pads and Assured brand drugs.

The letter -- sent earlier this month to Greenbrier International Inc., which does business as Dollar Tree -- describes Dollar Tree's receipt of adulterated drugs from manufacturers and suppliers that had received separate FDA warning letters last year and were placed on "import alert."

The letter outlines "multiple violations" of manufacturing practices at those contract manufacturers used to produce Dollar Tree's Assured Brand over-the-counter drugs as well as other drug products sold at Dollar Tree and Family Dollar stores.

Now, in its warning letter to Dollar Tree, the FDA is requesting that the company implement a system to ensure that it does not import adulterated drugs.

"Americans expect and deserve drugs that are safe, effective and that meet our standards for quality. The importation and distribution of drugs and other products from manufacturers that violate federal law is unacceptable," Donald D. Ashley, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research, said in a news release on Thursday.

"In this case, Dollar Tree has the ultimate responsibility to ensure that it does not sell potentially unsafe drugs and other FDA-regulated products to Americans," he said. "We will remain vigilant in our efforts to protect the U.S. public from companies who put the health of Americans at risk -- whether through the manufacturing and distribution of products we regulate or other means."

In response, the Dollar Tree company, which operates stores under the Dollar Tree and Family Dollar brands, said that it is cooperating with the FDA and plans to meet with the agency.

"We are committed to our customers' safety and have very robust and rigorous testing programs in place to ensure our third-party manufacturers' products are safe," Randy Guiler, vice president of investor relations at Dollar Tree, said in a company statement on Thursday.

"Each of the items referenced in the report are topical, and not ingestible, products. As always, we are cooperating with the US Food and Drug Administration (FDA). We plan to meet with the FDA in the near future and expect that our plans will satisfy their requirements in all regards," the statement said.

The company has 15 working days to respond to the FDA in writing, the warning letter says, and "failure to promptly correct the violations may result in legal action without further notice including, without limitation, seizure and injunction."

The warning letter notes how some of the drug products came from Shanghai Weierya Daily Chemicals Factory and Hangzhou Zhongbo Industrial Company Ltd., which the letter details have shown a pattern of serious violations of the law, such as not testing raw materials or drugs for pathogens and quality.

The FDA encourages health care professionals and consumers to report any adverse events that might have occurred while using over-the-counter drug products from the contract manufacturers.

Mississippi Coronavirus Cases

Data is updated nightly.

Cases: 314710

Reported Deaths: 7254
CountyCasesDeaths
DeSoto21646260
Hinds20369416
Harrison17949309
Rankin13643278
Jackson13450246
Madison10113217
Lee9986174
Jones8384163
Forrest7689152
Lauderdale7198240
Lowndes6403148
Lamar623686
Lafayette6203119
Washington5341134
Bolivar4802132
Oktibbeha462998
Panola4596107
Pearl River4519146
Marshall4450103
Warren4393121
Pontotoc420872
Monroe4115133
Union411176
Neshoba4031176
Lincoln3969110
Hancock379586
Leflore3498125
Sunflower336290
Tate334784
Pike3327105
Scott316274
Alcorn313368
Yazoo311770
Itawamba300577
Copiah297465
Coahoma295579
Simpson295388
Tippah288768
Adams286982
Prentiss280060
Marion269380
Leake268473
Wayne262841
Grenada261587
Covington259881
George248148
Newton246862
Winston227581
Tishomingo227067
Jasper221148
Attala214473
Chickasaw208057
Holmes189174
Clay185554
Stone182833
Tallahatchie178941
Clarke178080
Calhoun170932
Yalobusha164638
Smith162534
Walthall134245
Greene130633
Lawrence128724
Montgomery127142
Noxubee126734
Perry126338
Amite123142
Carroll121829
Webster114532
Jefferson Davis107133
Tunica105726
Claiborne102430
Benton100025
Humphreys96733
Kemper95828
Franklin83923
Quitman81116
Choctaw76418
Wilkinson67531
Jefferson65728
Sharkey50217
Issaquena1686
Unassigned00

Alabama Coronavirus Cases

Cases: 539829

Reported Deaths: 11038
CountyCasesDeaths
Jefferson798271529
Mobile41261809
Madison35132506
Tuscaloosa25915455
Shelby25294249
Montgomery24705593
Baldwin21392310
Lee15987172
Calhoun14569319
Morgan14422280
Etowah13918353
Marshall12275225
Houston10641282
Elmore10147206
Limestone10065151
St. Clair9946245
Cullman9761194
Lauderdale9457243
DeKalb8865188
Talladega8339176
Walker7260278
Autauga7001108
Jackson6836112
Blount6771139
Colbert6320135
Coffee5578118
Dale4876113
Russell445138
Chilton4369113
Franklin426282
Covington4138118
Tallapoosa4044153
Escambia394777
Chambers3590123
Dallas3568153
Clarke351461
Marion3137101
Pike311977
Lawrence302698
Winston275773
Bibb264564
Geneva254078
Marengo249665
Pickens234862
Barbour232056
Hale223978
Butler219069
Fayette212662
Henry189643
Cherokee184645
Randolph182442
Monroe178141
Washington167739
Macon161150
Clay157157
Crenshaw153557
Cleburne149641
Lamar143236
Lowndes140553
Wilcox127430
Bullock123242
Conecuh110829
Coosa109228
Perry107826
Sumter104932
Greene92634
Choctaw61024
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