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Browse by Category : Recalls

Mobius brand Mitosol (mitomycin for solution) Kit for Ophthalmic Use: Recall-May Not be Sterile

January 14th, 2013 | Author: | Category: health news, recalls

AUDIENCE: Ophthalmology

ISSUE: Mobius Therapeutics announced that it is conducting a voluntary recall of 2 lots of Mitosol (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use. The company cannot exclude the possibility that the affected lots may be non-sterile.These two lots of Mitosol (mitomycin for solution) Kits may contain a strain of yeast on one or more parts in the kit and should be considered non-sterile and unsafe for use. Use of these products could result in serious eye problems/infections, including possible blindness.

BACKGROUND: The Mitosol Kit for Opthalmic Use is an antimetabolite indicated as an adjunct to glaucoma surgery. The recalled lot numbers and a list of the 20 states to which the product was distributed are listed in the firm press release. The recalled product was distributed between 10/22/2012 and 12/14/2012. Mobius has not received any report of adverse events related to this recall.

RECOMMENDATION: Customers with affected product in their possession should stop using the product immediately and contact Mobius at 1-877-393-6484, Option 2, for safe return of the product.

Read Article: FDA

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FDA MedWatch – ACTRA-Sx 500 Capsules by Body Basics Inc.: Recall – Undeclared Drug Ingredient

September 19th, 2012 | Author: | Category: recalls

ISSUE: Body Basics Inc. announced that it is conducting a voluntary nationwide recall of ACTRA-Sx 500 Dietary Supplement Capsules, Lot 008-A, Expiration December 2013.  The Company, through independent lab analysis, has confirmed the presence of Sildenafil Citrate, the active ingredient used in an FDA approved drug to treat Erectile Dysfunction (ED), making this product an unapproved new drug. Use of this product may pose a threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.

Read Article: FDA

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Qualitest Hydrocodone Bitartrate and Acetaminophen Tablets 10 mg/500 mg: Recall – Potential for Oversized Tablets

September 12th, 2012 | Author: | Category: recalls

AUDIENCE: Consumer, Health Professional

ISSUE:  Today, Qualitest, a subsidiary of Endo Health Solutions,issued a voluntary, nationwide retail level recall for one lot of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg. Bottles from the affected lot may contain tablets that have a higher dosage of acetaminophen, and as a result, it is possible that consumers could take more than the intended acetaminophen dose. Unintentional administration of tablets with increased acetaminophen content could result in liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day.

Read Article: FDA

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Cooper Lighting Recalls Shower Light Trim and Glass Lens Due to Impact and Laceration Hazards

September 6th, 2012 | Author: | Category: recalls

The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.  It is illegal to resell or attempt to resell a recalled consumer product.

Name of product:Shower light trim Units: About 50,400 Distributor: Cooper Lighting LLC, of Peachtree City, Ga. Hazard: The shower light’s trim and glass lens can fall from the ceiling fixture, posing an impact and laceration hazard to consumers. Incidents/Injuries: Cooper Lighting has received 407 reports of trim pieces falling and breaking, including laceration injuries to a consumer’s head and foot when struck by the light’s trim and lens as they fell from the ceiling fixture. Description:This recall involves All-Pro shower light trim models ERT701, RE-ERT 701, ERT702 and ERT703 with a glass lens and date codes 347 11 through 119 12. The model number and date code are marked on underside of the portion of the trim facing the ceiling.  The trim is used with light fixtures listed below.

Read Article: prnewswire

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Bosch Recalls SkilSaw Miter Saws Due to Laceration Hazard

July 11th, 2012 | Author: | Category: recalls

The Consumer Product Safety Commission has announced a recall of more than 22,000 miter saws imported by Robert Bosch Tool Corporation due to a laceration hazard. The agency found that the lower guard on the saw can break during use, increasing the risk of injury to the operator. The recall covers SkilSaw 10-inch compound miter saws. Staff Report, PR Newswire 07/10/2012

Read Article: PR Newswire

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Innovage Recalls Discovery Kids Lamps Due to Fire and Burn Hazards

July 11th, 2012 | Author: | Category: recalls

The Consumer Product Safety Commission has announced a recall of 300,000 kids animated marine and safari lamps due to fire and burn risks. The agency said the Discovery Kids lamps can short circuit and spark while in use. There have been 11 reports of short-circuiting, including three cases with property damage. Staff Report, PR Newswire 07/03/2012

Read Article: PR Newswire

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IKEA Recalls Track Lighting System Due to Electric Shock Hazard

July 5th, 2012 | Author: | Category: recalls

The Consumer Product Safety Commission has announced a recall of about 5,000 IKEA track lighting systems due to an electric shock hazard. The agency said the ground connections on the track lightings are defective, which can present risk of electric shock to users. There have been no injuries reported in association with the recalled products. Staff Report, PR Newswire 06/28/2012

Read Article: PR Newswire 

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Ceiling Mounted Light Fixtures Recalled by Thomas Lighting Due to Fire and Shock Hazards

June 20th, 2012 | Author: | Category: recalls

The Consumer Product Safety Commission has announced a recall of more than 83,000 ceiling lighting fixtures due to fire and shock hazards. Manufactured by Thomas Lighting, the agency said the socket wiring can degrade and expose charged wires. There have been 11 reports of defective fixtures, but no injuries occurred. Staff Report, PR Newswire 06/19/2012

Read Article:  PR Newswire

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Strollers Recalled by Kolcraft Due to Fingertip Amputation and Laceration Hazards

June 20th, 2012 | Author: | Category: recalls

The Consumer Product Safety Commission and Health Canada have announced a recall of more than 36,000 three- and four-wheeled strollers manufactured by Kolcraft Enterprises Inc. According to the agency, children or users can get their fingers caught in the locking mechanism when adjusting the handlebars. There have been five reports of injuries, including three children whose fingertips have been amputated, and two adults who suffered smashed or cut fingers.  Staff Report, PR Newswire  06/14/2012

Read Article: PR Newswire

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Nautilus Recalls Bowflex Dumbbells Due to Injury Hazard

June 20th, 2012 | Author: | Category: recalls

The Consumer Product Safety Commission has announced a recall of 17,000 Bowflex 1090 dumbbells due to an injury hazard. According to the agency, the weight selector dial on the weights can fail, causing plates to fall when the dumbbells are picked up. There have been three reports of injuries to users’ feet or legs associated with the recalled products. Staff Report, PR Newswire 06/07/2012

Read Article: PR Newswire

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