November 14, 2019

Sienna Laxative and Flawless Beauty Recalled for Mislabeling and Unapproved New Drug

Two products regulated by the FDA have been recalled; one, Sienna Laxative, for mislabeling, and the other, Flawless Beauty products, because it contains an unapproved new drug. No illnesses or adverse reactions have been reported.

The first recall is for Flawless Beauty products. In accordance with a Consent Decree of Permanent Injunction, the company is voluntarily recalling all lots of 19 different products that were sold individually or as part of multi-unit kits because they are unapproved new drugs.

These products were sold over the internet to U.S. and foreign customers. All glutathione products were sold in multi-vial whitening kits. The FDA believes that these drugs present serious public health risks. You can see the long list of recalled products at the FDA web site. Flawless Beauty is notifying customers by sending recall letters.

The second recall is for Senna Laxative, for mislabeling. One lot of Basics Drug Brand of Senna Laxatives is recalled. The product actually contains Naproxen Sodium, which is a NSAID.

Unintentional consumption of naproxen sodium could cause fatal adverse events in those with underlying illness, including a known allergy to the compound, cardiac, gastrointestinal, hepatic, and renal conditions, and patients who have recently undergone cardiac bypass graft surgery. People can also inadvertently overdose by taking another NSAID at the same time. Adverse events may include myocardial infarction, stroke, congestive heart failure, renal toxicity, bleeding, ulceration, or perforation of the stomach or the intestines. The populations most at risk for serious complications include children, pregnant women, nursing mothers, and surgical patients.

The recalled product is Basic Drugs Brand Senna Laxative, 8.6 mg Sennosides, a tablet that is used as a laxative. The product is packaged in 100 count bottles, with an outer neck seal and a child resistant cap. The lot number is Lot#352300, EXP: 01/19 printed on the bottom of the bottle. This product was sold nationwide to secondary distributors, retail pharmacies, and over the internet.

If you purchased either of these products, do not use them. Throw them away in a sealed container, or take them back to the place of purchase for a refund.

Warning

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