Sunday, June 17, 2018
Business

This week's product recalls

Slim Fortune, Lidiy, Slim Expert

Company: [email protected] Trade Inc.

Quantity: Undisclosed.

Why? The dietary supplements contain undeclared sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, making these products unapproved new drugs. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

What models? The 30-capsule bottle of Slim Fortune, Lidiy and Slim Expert.

Where sold? Directly to customers in Florida, through sales offices and at www.lidiy.com, www.slimfortune.com and www.slimexpert.com.

What to do? Call the company at (305) 763-6956 or email [email protected]

Market Pantry animal cookies

Company: D. F. Stauffer Biscuit Co. Inc.

Quantity: Undisclosed.

Why? The products may contain undeclared milk and eggs. People with an allergy or severe sensitivity to milk or eggs run the risk of serious or life-threatening allergic reactions if they consume this product.

What models? The 44-ounce Market Pantry white fudge coated animal cookies in bear-shaped jugs. For lot numbers and best-by dates, please see www.fda.gov/Safety/Recalls/ucm370813.htm.

Where sold? Target.

What to do? Call the company toll-free at 1-888-480-1988.

ForeCYTE mammary test device

Company: Atossa Genetics Inc.

Quantity: Undisclosed.

Why? The FDA raised concerns about instructions, certain promotional claims and the need for FDA clearance for certain changes made to the specimen collection process.

What models? ForeCYTE breast health test and the mammary aspiration specimen cytology test (MASCT) device. For further details, please see www.fda.gov/Safety/Recalls/ucm370782.htm.

Where sold? Through distributors and direct mail.

What to do? Call the company toll-free at 1-800-351-3902 or 1-888-219-4629.

Lidocaine HCL injection

Company: Hospira Inc.

Quantity: One lot.

Why? The product may contain visible particulate, which could cause serious health complications.

What models? The 1% Lidocaine HCI injection, USP, 10 mg/mL, 20 mL multiple-dose fliptop vial, NDC 0409-4276-01, lot 25-090-DK.

Where sold? Through health-care professionals.

What to do? Call Hospira toll-free at 1-800-441-4100 or email [email protected]

Emergency cricothyrotomy kit

Company: H&H Medical Corp.

Quantity: 6,619.

Why? The product has the potential for a defective cuff balloon on the provided endotracheal airway.

What models? The H&H emergency cricothyrotomy kit. For lot numbers and expiration dates, please see www.fda.gov/Safety/Recalls/ucm370775.htm.

Where sold? Through health-care professionals.

What to do? Call the company toll-free at 1-800-326-5708 or email [email protected]

Fabius anesthesia machines

Company: Drager USA.

Quantity: 152.

Why? The influence of mechanical forces – such as movement of the device, for example – may cause a failure of the automatic ventilation function of the device. If such a fault occurs, an audible and visual alarm is generated.

What models? Fabius GS Premium, Fabius OS, Fabius Tiro and Fabius Tiro D-M anesthesia machines.

Where sold? Through health-care professionals.

What to do? Call the company toll-free at 1-800-543-5047 or email [email protected]

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