FDA announces safety alerts, reviews for baby wipes, dietary supplement

Baby wipes recalled amid bacteria concerns; Sit and Slim II contains unapproved drug

PEMBROKE PARK, Fla. – The Food and Drug Administration announced its safety alerts and reviews for some widely used products, including baby wipes that may contain bacteria, undeclared drugs found in a product sold as a dietary supplement with weight loss claims and a pain reliever packaging mix-up.

Baby wipes recalled

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Nutek Disposables is recalling all lots of baby wipes it manufactured under the brand names Cuties, Diapers.com, Femtex, Fred's, Kidgets, Member's Mark, Simply Right, Sunny Smiles, Tender Touch and Well Beginnings because some packages may contain bacteria.

These wipes were distributed by Nutek to Walgreens, Sam's Club, Family Dollar, Fred's and Diapers.com prior to Oct. 21.

After receiving several complaints of odor and discoloration, Nutek conducted microbial testing that showed the presence of the bacteria Burkholderia cepacia in some of these products.

The bacteria poses little risk to healthy people, but those who have certain medical conditions like weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to infections.

Since Oct. 3, the date of the original withdrawal, the company had only received one report of irritation, Since that time, numerous complaints received by the company include rash, irritation, infections, fevers, gastro-intestinal issues and respiratory issues.

Dietary supplement contains unapproved drug

Sit and Slim II, promoted and sold as a dietary supplement, has been found to contain undeclared phenolphthalein, sibutramine or a combination of both, which makes it an unapproved drug.

Sibutramine was a controlled, FDA-approved substance for the treatment of obesity until it was removed from the U.S. market in 2010 for safety reasons. Phenolphthalein, once used in over-the-counter laxatives, is also not approved for marketing in the U.S. because of concerns that the substance can cause cancer.

These products pose a significant risk to those with a history of coronary artery disease, congestive heart failure, abnormal heart rhythm or stroke. Consumption of these pills could also cause potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use.

Salmonella concerns prompts Dermatend recall

Solace International is recalling all lots of Dermatend and Dermatend Ultra in all sizes and dosage forms because of salmonella concerns.

These products are promoted to remove moles, warts and skin tags.

Packaging mix-up leads to recall of pain reliever

Contract Packaging Resources, a drug repackaging company, is recalling 11,640 boxes of Assured brand naproxen sodium tablets because some cartons actually contain bottles of ibuprofen, a different pain reliever.

The affected products are boxes of Assured brand naproxen sodium tablets in the 15-count, 220 mg bottles (Lot #FH4102A) [SKU #122368/UPC #639277223685].

These and other alerts were prompted by reports the FDA received from health care professionals and the public through the agency's MedWatch website.

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