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

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

Posted: Nov 15, 2019 9:53 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.

New York Coronavirus Cases

County data is updated nightly.

Cases: 1611031

Reported Deaths: 47156
CountyCasesDeaths
Queens2061178675
Kings2046548996
Suffolk1595713049
Nassau1452902890
Bronx1402445807
Westchester1055502078
New York1005843852
Erie640661585
Richmond558791558
Monroe51913977
Rockland37948884
Orange36102720
Onondaga32054620
Dutchess21862404
Albany20526328
Oneida19519475
Niagara15100309
Broome14412333
Saratoga11723145
Schenectady10685177
Ulster9854226
Rensselaer8860130
Putnam820486
Chautauqua7213122
Chemung6397130
Oswego593589
Ontario569988
Steuben5452137
St. Lawrence533680
Cayuga531287
Jefferson468163
Sullivan466259
Herkimer4531106
Wayne440964
Genesee4335118
Cattaraugus432476
Madison379284
Livingston347855
Clinton346826
Tompkins341442
Columbia334794
Fulton324580
Montgomery3121105
Cortland310260
Allegany285681
Warren279555
Wyoming277848
Tioga277156
Greene259869
Orleans242280
Chenango239069
Washington227952
Otsego226743
Lewis202630
Franklin199612
Seneca156453
Delaware146933
Essex131726
Schoharie117612
Yates101126
Schuyler85212
Hamilton2772
Unassigned217137
Out of NY0191
Rome
Partly Cloudy
26° wxIcon
Hi: 33° Lo: 22°
Feels Like: 26°
Binghamton
Clear
27° wxIcon
Hi: 34° Lo: 24°
Feels Like: 19°
Rome
Partly Cloudy
26° wxIcon
Hi: 35° Lo: 26°
Feels Like: 26°
Rome
Mostly Cloudy
26° wxIcon
Hi: 29° Lo: 20°
Feels Like: 26°
WKTV Radar
WKTV Temperatures
WKTV Severe Weather
2021 Golfer's Paradise Card - 21 Courses for only $99.99
Saluting Those Who Are Proud 2 Serve