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: 291891

Reported Deaths: 6605
CountyCasesDeaths
DeSoto19470226
Hinds18555383
Harrison16385273
Rankin12498260
Jackson12401216
Lee9635160
Madison9353193
Jones7836144
Forrest7055135
Lauderdale6735225
Lowndes5989137
Lamar579379
Lafayette5688113
Washington5124128
Bolivar4567120
Oktibbeha438091
Panola424092
Warren4091113
Pearl River4070127
Pontotoc406066
Marshall397992
Monroe3971125
Union391372
Neshoba3746166
Lincoln343799
Hancock337773
Leflore3346118
Sunflower315785
Tate299172
Pike297792
Scott291367
Alcorn289760
Itawamba288471
Yazoo282662
Tippah275265
Copiah273357
Coahoma272265
Simpson269278
Prentiss267158
Leake250870
Wayne250140
Marion249478
Covington246277
Grenada244576
Adams232374
George229545
Newton222551
Winston220174
Tishomingo210965
Jasper210343
Attala205669
Chickasaw200250
Holmes181470
Clay177348
Stone170729
Tallahatchie169039
Clarke167671
Calhoun155327
Smith151131
Yalobusha141936
Greene126333
Walthall123040
Noxubee122429
Montgomery120537
Perry120133
Lawrence118420
Carroll117123
Amite110632
Webster108629
Jefferson Davis99831
Tunica97923
Claiborne97329
Benton92524
Humphreys91226
Kemper89222
Quitman76614
Franklin75319
Choctaw69316
Wilkinson62226
Jefferson60827
Sharkey48817
Issaquena1676
Unassigned00

Alabama Coronavirus Cases

Cases: 488973

Reported Deaths: 9660
CountyCasesDeaths
Jefferson703321342
Mobile35725716
Madison32088437
Tuscaloosa23913404
Montgomery22369481
Shelby21714209
Baldwin19554263
Lee14827147
Morgan13529243
Etowah13091309
Calhoun13063281
Marshall11197202
Houston10019255
Limestone9303130
Elmore9283179
Cullman8856176
St. Clair8747214
Lauderdale8541209
DeKalb8419173
Talladega7424161
Walker6466240
Jackson6450101
Autauga614384
Blount6058125
Colbert5973118
Coffee522299
Dale4606106
Russell400530
Franklin396575
Covington3918105
Chilton380096
Escambia375970
Tallapoosa3533138
Clarke342348
Dallas3385139
Chambers3382102
Pike292471
Lawrence280685
Marion277492
Winston244563
Marengo243454
Bibb243259
Geneva238168
Pickens223453
Barbour208450
Hale208064
Fayette198755
Butler194865
Henry181741
Cherokee175737
Monroe165538
Randolph161240
Washington155832
Crenshaw143052
Clay142554
Macon140344
Cleburne136139
Lamar130632
Lowndes130148
Wilcox120525
Bullock116033
Conecuh106423
Perry104927
Sumter98231
Greene86732
Coosa86323
Choctaw54723
Out of AL00
Unassigned00
Tupelo
Partly Cloudy
56° wxIcon
Hi: 76° Lo: 41°
Feels Like: 56°
Columbus
Cloudy
56° wxIcon
Hi: 76° Lo: 39°
Feels Like: 56°
Oxford
Partly Cloudy
50° wxIcon
Hi: 70° Lo: 45°
Feels Like: 50°
Starkville
Cloudy
52° wxIcon
Hi: 77° Lo: 43°
Feels Like: 52°
WTVA Radar
WTVA Temperatures
WTVA Severe Weather