Basak, S. "Sun Pharma Recalls 400,000 Bottles of Drugs in U.S., FDA Says," Bloomberg News, May 8, 2014.
India's largest drug manufacturer Sun Pharmaceutical Industries Ltd., is recalling nearly 400,000 bottles of its generic form of the anti-depressant Effexor (Venlafaxine) and the antihistamine Cetirizine because the pills fail to dissolve properly.
 Basak, S. "Sun Pharma Recalls 400,000 Bottles of Drugs in U.S., FDA Says," Bloomberg News, May 8, 2014.
Amid concerns over the potential to spread undetected cancer beyond the uterus, Johnson & Johnson (J&J) has suspended the sale of its laparoscopic power morcellators until their role in fibroid treatment is better understood. Laparoscopic power morcellation uses a medical device to divide the uterine tissue into smaller pieces or fragments so it can be removed through a small incision in the abdomen. The withdrawal follows an FDA warning that discouraged the use of laparoscopic power morcellators to remove fibroids because of a risk of spreading hidden cancer (MedWarn Alert, 04/17/14). J&J is not recalling the device because power morcellation may still be the best option for some patients after risk evaluation and informed consent.
 Reuters, "J&J suspends sale of device used in fibroid surgery," April 30, 2014.
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.
Nano Well-being Health Inc. has issued a voluntary recall of Super Arthgold, 500 mg capsules. Super Arthgold is a dietary supplement used for joint pain and arthritis. FDA lab analysis has found the product to contain chlorzoxazone, diclofenac and indomethacin, making it an unapproved new drug. Use of this product may result in fatal adverse events in patients with underlying illnesses, including known allergy to the hidden ingredients, cardiac, gastrointestinal, hepatic, and renal conditions as well as patients who recently undergone cardiac bypass graft surgery. Consumers would be unaware that the product contains Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (and other ingredients) and may inadvertently overdose by taking another NSAID concurrently, thus increasing the risk for NSAID associated adverse events, which include but are not limited to, myocardial infarction, stroke, congestive heart failure, renal toxicity, and bleeding, ulceration, or perforation of the stomach or intestines. Affected lots include:
Covidien is voluntarily recalling some of its Pipeline and Alligator Brain Embolism devices after discovering a potentially lethal problem with the guidewires. The guidewires are coated with a plastic designed to reduce friction. The problem arises when the plastic coating on the guidewire delaminates and detaches from the devices, which could potentially lead to embolic occlusion with the risk of stroke and/or death. 32 Pipeline embolization devices and 621 Alligator retrieval devices are affected by this recall. Read more about Recalls.
 Recall -- Firm Press Release, "Covidien Implements Voluntary Recall of its Pipeline(™) Embolization Device and Alligator(™) Retrieval Device," April 11, 2014.
Teva Pharmaceutical has issued a voluntary recall of certain lots of the antidepressant Duloxetine Delayed-Release Capsules (generic Cymbalta) due to a customer complaints of capsule breakage. The recall affects 1,050,266 bottles of drugs. FDA has classified the recall as Class II. Teva is also voluntarily recalling 257,832 cylinders of inhaled asthma drug QVAR®, manufactured for Teva by 3M in California. The drug is being recalled because it failed testing for impurity and degradation specifications. FDA has classified the recall as Class III. Read more about Recalls.
 FDA, Enforcement Report - Week of April 9, 2014.
Thoratec Corporation has issued a voluntary worldwide recall of its HeartMate II LVAS Pocket System Controller in order to update its labeling and training materials. Thoratec received five reports of serious injury and four reports of death because some patients and caregivers had difficulty with the process of changing from the primary system controller to a back-up system controller. All reports were linked to patients whose HeartMate II LVAS device was originally attached to an older model of controller, the EPC System controller. When the Pocket System Controller became available, patients were switched from the EPC System Controller to the Pocket System Controller. However, these patients did not receive intensive training on connecting the new controller. The design differences between the EPC System Controller and the Pocket System Controller require a different approach to how the device is connected. If the controller is not properly connected, the device cannot function.
FDA has given the recall the most serious classification --Class I -- because use of this product may cause serious adverse health consequences, including death. Consumers who have the HeartMate II LVAS Pocket Controller should immediately contact their doctor for retraining on use of the device and to receive updated Patient Handbook Information. No product needs to be returned.
 FDA, "Thoratec Corporation, HeartMate II LVAS Pocket System Controller - Insufficient Labeling and Training for Patients Switched from the EPC Controller," March 4, 2014.
Intuitive Surgical is voluntarily recalling certain lots of Single-Site® 5mm Reusable Curved Cannulae because incorrect placement of the cannulae in the Single-Site port could potentially cause damage. If it becomes damaged during surgery, there is the possibility that the cannula or instrument may come in inadvertent contact with tissue. In addition, the surgeon may need to replace the damaged cannula during surgery or convert to a multi-port approach if another cannula is not available.
The da Vinci Surgical System is a medical robotic technology used for minimally invasive surgery. When used according to instructions, the cannulae are unlikely to become damaged. The total reported cannulae damage occurrence rate is approximately 0.52%. In addition to the recall, Intuitive Surgical is revising its Single-Site labeling to instruct users how to inspect cannulae prior to use and to appropriately handle cannulae during use.
Affected lots were manufactured between December 2010 and August 2012. All affected cannulae will be replaced with a new version that can withstand higher force and is less likely to become damaged by incorrect placement. For more information see intuitivesurgical.com.
 Intuitive Surgical "Important Product Information" (March 26, 2014).
GlaxoSmithKline's popular over-the-counter weight-loss drug, Alli, is being recalled following reports of tampering. So far, 20 bottles have been reported to show signs of tampering. Tablets and capsules of various shapes and colors were reported to be found inside bottles. The true Alli is a turquoise blue capsule with a dark brand imprinted with the text "60 Orlistat", the active compound which prevents the absorption of fat. Additionally, some bottles were missing labels and had tamper-evident seals that were not authentic. GlaxoSmithKline is conducting an investigation with the FDA to determine what the false pills are and how the tampering may have occurred. The suspect bottles were purchased in Alabama, Florida, Mississippi, New York, North Carolina and Texas. There are no reports of tampering outside the U.S.
 Smith, Aaron, "Alli weight-loss drug recalled for tampering" CNNMoney (March 27, 2014).
New Life Nutritional Center is recalling all lots of “Super Fat Burner capsules, Maxi Gold capsules and Esmeralda softgels” after FDA analysis revealed the products contain undeclared active pharmaceutical ingredients: sibutramine, phenolphthalein or a combination of both sibutramine and phenolphthalein.
Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 (due to increased risk of seizures, heart attacks, arrhythmia and strokes). Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States. These undeclared ingredients make these products unapproved new drugs for which safety and efficacy have not been established. At this time no illnesses or injuries have been reported to New Life Nutritional Center in connection with these products. For more information see FDA's full press release.
 FDA Firm Press Release, " New Life Nutritional Center Issues Voluntary Recall of Super Fat Burner, Maxi Gold and Esmeralda Dietary Supplements Due to the Presence of Undeclared Sibutramine and Phenolphthalein" (March 25, 2014).