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FDA Warning Letter to DePuy RE: TruMatch™ Personalized Solutions System and Corail® Hip System

DePuy Orghopaedics, a division of Johnson & Johnson, received a warning letter from the FDA Department of Health and Human Services on August 19th, 2010. The letter is in regard to unauthorized marketing of the TruMatch™ Personalized Solutions System and the Corail® Hip System. We have republished this letter in its entirety here.

Natural Wellness, Inc. Recalls Masxtreme Capsules, Marketed as a Dietary Supplement – 08/24/10

Natural Wellness is announcing that it is conducting a nationwide voluntary recall of MasXtreme, Lot # 907043, UPC 094922300805. Laboratory analysis conducted by FDA has determined the product contains undeclared amounts of Aminotadalafil, an analog of tadalafil. Tadalafil is an FDA-Approved drug used to treat erectile dysfunction (ED), making the MasXtreme an unapproved new drug.

J & H Besta Expands Nationwide Recall of Slim- 30 Herb Supplement to Include Lot 6032101 Found to Contain an Undeclared Drug Ingredient

J & H Besta Corp. of Hicksville, NY, has been informed by the Food and Drug Administration (FDA) that FDA lab analysis of Slim-30 Herb Supplement Lot 6032101 distributed by the company was found to contain undeclared Desmethyl Sibutramine, similar in structure to Sibutramine. Sibutramine is an FDA-approved drug used as an appetite suppressant for weight loss. The FDA has not approved Slim-30 Herbal Supplement, therefore the safety and effectiveness of the product is unknown. On July 16, 2010, J & H Besta had recalled Lot/Code 032009 and is now expanding the recall action to include Lot 6032101.

Glow Industries, Inc. Issues Nationwide Recall of Mr. Magic Male Enhancer from Don Wands Amended

Glow Industries, Inc., Perrysburg, OH, announced today that it is initiating a voluntary nationwide recall of the company’s product sold under the name of Mr. Magic Male Enhancer from Don Wands. Glow Industries, Inc. is conducting this voluntary recall after being informed by the Food and Drug Administration (FDA) that lab analysis has found the Mr. Magic Male Enhancer from Don Wands capsules to contain Hydroxythiohomosildenafil and Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used in the treatment of male Erectile Dysfunction (ED), making Mr. Magic Male Enhancer an unapproved new drug. These active ingredients are not listed on the product label. Product manufactured containing lot numbers 9041401, 251209 and 8121904 are included in this recall.

NBTY Acquisition LLC Dba Leiner Health Products Issues Allergy Alert on Undeclared Soy in Air Shield Effervescent Tablets, Air Protector Effervescent Tablets, Immune System Support Effervescent, and Airhealth Effervescent Tablets And Stick Packs

BTY Acquisition LLC, dba Leiner Health Products of Ronkonkoma, New York is recalling Air Shield, Air Protector, Immune System Support, and AirHealth Effervescent 10 Tablet containers and Stick Packs, 8 stick containers, because they may contain undeclared Soy. People who have an allergy or severe sensitivity to Soy run the risk of serious or life-threatening allergic reaction if they consume these products.

Prolatis’ Recalls Prolatis’ Marketed as Dietary Supplement

Prolatis’ announced today that it is conducting a voluntary nationwide recall of the company’s product sold under the name Prolatis’. Prolatis’ is conducting a voluntary recall after being informed by the Food and Drug Administration (FDA) that lab analysis has found Prolatis’ to contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED), making Prolatis’ an unapproved drug. The active drug ingredient is not listed on the product label. Product manufactured prior to August 9, 2010 is included in this recall. Prolatis’ is sold nationwide in double blister packs and 40 count bottles.

Novacare Recalls Products Found to Contain Undeclared Drug Ingredient Sulfoaildenafil

Novacare LLC announced today that it is conducting a voluntary nationwide recall of products sold under the following names: Stiff Nights, Aziffa, Size Matters, Erex, Mojo, Hard Drive, Eyeful, Red Magic, Straight Up, Zotrex, Monster Excyte, WOW, Xaitrex, Verect, Prolatis, Xytamax, Maxyte, Libidinal, OMG, OMG45, and Zilex (with Golden Spear).

Ikaria Recalls INOMAX DS Drug-Delivery System

Ikaria, Inc. announced today that its INOMAX® DS drug-delivery systems in the United States are being voluntarily recalled due to the potential failure of a pressure switch which may have an impact on the administration of INOMAX® (nitric oxide) for inhalation to patients. This potential failure was identified by Ikaria as part of its ongoing quality monitoring and review processes. This class I recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). All INOMAX DS systems in Canada also are being voluntarily recalled.

EZVille, Ltd. Recalls Revivexxx® Extra Strength Found to Contain an Undeclared Drug Ingredient

EZVille, Ltd. of Ronkonkoma, NY, has been informed by the US Food and Drug Administration (FDA) that FDA lab analysis of Revivexxx® Extra Strength distributed by the company was found to contain undeclared tadalafil. Tadalafil is an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making Revivexxx® Extra Strength an unapproved drug.

EZVille, Ltd. Issues a Voluntary Nationwide Recall of Solo Slim® Found to Contain an undeclared Drug Ingredient

RECALLS, MARKET WITHDRAWALS, & SAFETY ALERTS ARCHIVE FOR RECALLS, MARKET WITHDRAWALS & SAFETY ALERTS ENFORCEMENT REPORTS INDUSTRY GUIDANCE MAJOR PRODUCT RECALLS VAR CID_ID, CID_ITEM, CID_CLASS, CONTENT_PAGE = 0; VAR BREAKOUT = FALSE; VAR CID = WINDOW.LOCATION.HREF.SPLIT(“/”); VAR CID_FILENAME = CID; IF(CID_FILENAME.TOLOWERCASE() == “DEFAULT.HTM” || CID_FILENAME.TOLOWERCASE() == “INDEX.HTM” ) { CID_ID = DOCUMENT.GETELEMENTBYID(“LEFT_NAV_2202″); IF(CID_ID.CLASSNAME == “SIDEMENU_PARENT”) { BREAKOUT = TRUE; } } ELSE { CID_ITEM = CID_FILENAME.SPLIT(“.”); CID_ID = DOCUMENT.GETELEMENTBYID(CID_ITEM.TOUPPERCASE()); CONTENT_PAGE = 1; } IF(BREAKOUT == FALSE) { IF (CID_ID && CONTENT_PAGE == 1) { VAR CID_IMG_TEXT=” “; VAR CID_ID_INNERTEXT = CID_ID.INNERHTML; CID_IMG_TEXT += CID_ID_INNERTEXT; CID_ID.INNERHTML = CID_IMG_TEXT+”"; } ELSE IF(CID_ID) { VAR CID_IMG_TEXT=”“; VAR CID_ID_INNERTEXT = CID_ID.INNERHTML; IF((CID_ID_INNERTEXT.TOLOWERCASE()).INDEXOF(“”) >= 0) { VAR INDEXER = (CID_ID_INNERTEXT.TOLOWERCASE()).INDEXOF(“”); VAR BEG = CID_ID_INNERTEXT.SUBSTRING(0, INDEXER); VAR END = CID_ID_INNERTEXT.SUBSTRING(INDEXER); CID_ID.INNERHTML = CID_IMG_TEXT + BEG + “” + END; } ELSE { CID_IMG_TEXT += CID_ID_INNERTEXT; CID_ID.INNERHTML = CID_IMG_TEXT+”"; } } } RECALL — FIRM PRESS RELEASE

 

Lundbeck Inc. Recalls Two Lots of NeoProfen® (ibuprofen lysine) Injection

Deerfield, Ill. Lundbeck Inc. has voluntarily recalled two lots of NeoProfen® (ibuprofen lysine) Injection that failed to meet a visible particulate quality requirement. These two lots are the only lots currently available to prescribers and therefore the recall will result in a temporary drug shortage. This voluntary recall is the result of the company’s inspections of the two product lots of NeoProfen.

Lundbeck Inc. Announces Recall of Two Lots of NeoProfen® (ibuprofen lysine) Injection Recall will Result in Temporary Product Shortage

Lundbeck Inc. has voluntarily recalled two lots of NeoProfen® (ibuprofen lysine) Injection that failed to meet a visible particulate quality requirement. These two lots are the only lots currently available to prescribers and therefore the recall will result in a temporary drug shortage. This voluntary recall is the result of the company’s inspections of the two product lots of NeoProfen.

Nutraloid Labs Inc. Recalls Two Dietary Supplements Found to Contain Undeclared Drug Ingredient

Nutraloid Labs Inc. announced today that it is conducting a voluntary nationwide recall of two dietary supplement products sold under the names: ejaculoid XXTREME and stimuloid II.

Bausch + Lomb Recalls PreserVision Eye Vitamin AREDS 2 Formula

MADISON, N.J. – Bausch + Lomb is conducting a voluntary recall of its PreserVision® Eye Vitamin AREDS 2 Formula with Omega 3 soft gels, only available within the United States.

Bausch + Lomb chose to initiate this recall based on a small number of reports predominantly within a specific age group, age 70 and older, who reported difficulty swallowing or a choking sensation when taking the soft gel.

Airgas South Initiates Precautionary Voluntary Recall of Medical Gas Products at Chattanooga, TN Facility

Airgas South, Inc., a distributor of industrial, medical, and specialty gases, today announced an expanded voluntary recall of medical gas products filled at its Chattanooga, Tennessee facility. The recall is being initiated as a precautionary measure because these products may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices (cGMPs). These practices help assure that drug products meet required quality standards for quality, purity and potency. The potential for serious medical events is remote and other than one initial complaint concerning a contaminated cylinder which triggered the initial recall, Airgas South is not aware of any other confirmed events involving cylinder contamination. The Company has no reason to believe that other contaminated cylinders will be found.

J & H Besta Corp. Recalls Joyful Slim Herb Supplement Found to Contain an Undeclared Drug

J & H Besta Corp. of Hicksville, NY, has been informed by the Food and Drug Administration (FDA) that FDA lab analysis of Joyful Slim Herb Supplement distributed by the company was found to contain undeclared Desmethyl Sibutramine. Sibutramine is an FDA-approved drug used as an appetite suppressant for weight loss. The FDA has not approved this product, therefore the safety and effectiveness of the product is unknown.

Cook Recalls Certain Ciaglia Blue Rhino and Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays

Cook has initiated a voluntary recall of certain lots of its Ciaglia Blue Rhino and Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays that contain a Covidien 6PERC or 8PERC Shiley™ Tracheostomy Tube.

Good Health, Inc. Recalls Vialipro – Contains Prescription-Only Ingredients

Good Health, Inc. announced today that it is conducting a voluntary nationwide recall of the company’s dietary supplement Vialipro for sexual enhancement sold under the Lot Numbers listed below.

J & H Besta Corp. Recalls Slim- 30 Herb Supplement Found to Contain an Undeclared Drug Ingredient

J & H Besta Corp. of Hicksville, NY, has been informed by the Food and Drug Administration (FDA) that FDA lab analysis of Slim-30 Herb Supplement distributed by the company was found to contain undeclared N-Desmethyl Sibutramine and traces of Sibutramine. Sibutramine is an FDA-approved drug used as an appetite suppressant for weight loss. The FDA has not approved this product, therefore the safety and effectiveness of the product is unknown.

Bristol-Myers Squibb Recalls Coumadin (R) 1 mg Tablet Blister Packs

Bristol-Myers Squibb is recalling three lots of physician sample blister packs of Coumadin® 1 mg tablets and five lots, of Coumadin 1 mg tablet hospital unit dose (HUD) blister packs.

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