Recall Round-Up March-April 2014

Drugs

• Pfizer's Effexor XR® and Greenstone Brands (venlafaxine HCL 150 mg extended-release capsules) because of a foreign tablet in one bottle
• Pain Free By Nature (reumofan plus tablets) for containing undeclared methocarbamol and diclofenac
• Shire Pharmaceuticals VPRIV® for injection for presence of visible particulate matter, identified as stainless steel and barium sulfate
• Pleo Homeopathic Drug Products for penicillin contamination
• Super Fat Burner, Maxi Gold, and Esmeralda dietary supplement for being an unapproved new drug
• Bella Vi dietary supplement for undeclared sibutramine and phenolphthalein
• Alli Weight Loss Product because of concerns about authenticity of product
• African Black Ant, XZen Gold, Xzone and other dietary supplements for being unapproved new drugs
• Thinogenics weight loss capsules for undeclared sibutramine
• Hospira propofol injectable emulsion, USP, for visible particulates
• CUBICIN daptomycin for injection because of the presence of particulate matter
• Hospira 1% lidocaine HCL injection, USP, because of the presence of visible particulates
• Hospira 0.25% Marcaine(™), 10 mL, single-dose vial - preservative free, for discolored solution with visible particles embedded in the glass
• Nano Well-being Health dietary supplement - Super Arthgold, for being an unapproved new drug.

Medical Devices

• Playtex AC/DC power adapters used with breast pump for potential for electric shock
• Greatbatch, Inc. Standard Offset Cup Impactors because Instructions for Use did not meet requirements for sterility assurance
• HeartMate II LVAS Pocket System Controller because of difficulties in changing from a primary system controller to a back-up controller

The list above provides information gathered from press releases and other public notices about certain recalls of FDA-regulated drugs, biologics, and medical devices. Not all recalls have press releases or are posted. See FDA's Recall pages for a more complete listing.