Norgestimate and Ethinyl Estradiol Recalled Over Packaging Errors

February 27, 2012

Huffington Post

For the second time this year, certain birth control medications are being recalled over a packaging error.

Glenmark Generics Inc. has announced a voluntary recall of seven lots of its Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg.

The recall is being implemented because of a packaging error, where select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date visible only on the outer pouch.

Click here for the full report from the Huffington Post

Blue Buffalo Dog Food Recalled

October 12th, 2010

WebMD

By: Daniel J. DeNoon

The Blue Buffalo Company Ltd. is recalling several lots of its “Blue” brand dog food, which may have excessive amounts of vitamin D.

So far 36 dogs have had symptoms, which include lethargy, unusually frequent water consumption and urination, and, in some cases vomiting. All recovered with no long-term effects noted to date.

Blue Buffalo CEO Bill Bishop says consumers whose dogs show any adverse reaction to the recalled products should have their pet checked by a veterinarian. He promises to reimburse consumers for any veterinary or testing expenses related to illness caused by company products.

Bishop says the company’s ingredient supplier had produced a vitamin D supplement immediately before preparing ingredients for the Blue brand dog food. The company thinks that some of this vitamin D was “carried over” into the Blue Buffalo products.

In a news release, Bishop says the “increased vitamin D presents no serious health risk, and any negative reaction to these products has been confined to a very small segment of the canine population who appear to be sensitive to higher levels of vitamin D.”

No other Blue brand dry or canned pet foods are involved in this recall, and only the specific code dates of these products are involved:

Blue Wilderness Chicken Flavor dry dog food	4.5 lb	“Best If Used By JUL2611Z” “Best If Used By JUL2711Z” & “Best If Used By JUL2811Z”
Blue Wilderness Chicken Flavor dry dog food	11 lb	“Best If Used By JUL1211B”
Blue Wilderness Chicken Flavor dry dog food	24 lb	“Best If Used By JUL1211B” & “Best If Used By JUL1311B”
Blue Basics Limited Ingredient Formula Salmon and Potato Recipe dry dog food	11 lb	“Best If Used By AUG2111B” & “Best If Used By AUG2211B”
Blue Basics Limited Ingredient Formula Salmon and Potato Recipe dry dog food	24 lb	“Best If Used By AUG2111B” “Best If Used By SEP2311P” & “Best If Used By OCT2611P”
Blue Life Protection Formula Natural Chicken & Brown Rice Recipe Large Breed Adult dog food	30 lb	“Best If Used By SEP2211P” “Best If Used By SEP2311P” & “Best If Used By OCT2611P”

Consumers who have purchased any of the products being recalled are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 877-523-9114 from 8 a.m. to 8 p.m. Eastern time or visit the company web site, bluebuffalo.com.

Click here for the full report from WebMD

FDA Investigates Serious Tylenol Recall

May 26, 2010

CNNMoney.com

By Parija Kavilanz

The Food and Drug Administration is looking into reports of at least 775 serious side effects from drugs recalled by McNeil, a division of Johnson & Johnson, according to a source close to a Congressional investigation.

Included in the reports were 30 deaths, nearly all of which were found to not be tied to McNeil’s recall of Tylenol, Motrin and Benadryl drugs from Jan. 1, 2008 through April 30, 2010, according to another source close to the investigation.

The FDA is also investigating reports of several hundred serious side effects — or “adverse events” — and seven deaths since May 1, when McNeil recalled 50 children’s versions of these non-prescription medicines because of serious quality and safety concerns.

The FDA’s investigation into the recalls is ongoing and the agency would not comment on the matter.

Adverse event reports are consumer complaints of a serious side effect associated with the use of a medical product, according to the FDA. Adverse events could include death, hospitalization, disability and other health complications.

The House Committee on Oversight and Government Reform has scheduled a hearing on May 27 to examine the recall.

Following the most recent recall, Johnson & Johnson (JNJ, Fortune 500) has suspended production at McNeil’s facility in Fort Washington, Penn., that manufactured the children’s drugs.

McNeil’s latest recall is its fourth in the past seven months:

In November 2009, five lots of Tylenol Arthritis Pain 100 count with the EZ-open cap were recalled for unusual odor leading to nausea, stomach pain, vomiting and diarrhea.
In December, the recall was expanded to include all product lots of Tylenol Arthritis Pain caplet 100 count bottles with the red EZ-open cap.
In January 2010, the recall was widened to an undisclosed number of Tylenol, Motrin and other over-the-counter drugs after complaints of consumers feeling sick from an odor.

McNeil has maintained that its recall of the children’s drugs was not “undertaken on the basis of adverse medical events” but as a precautionary measure.

“We track all adverse events and thoroughly investigate all serious adverse cases that are reported and, in turn, report these to the FDA, whether or not the event may be caused by our products,” McNeil said in a statement Tuesday.

The FDA, which earlier this month issued a scathing 17-page inspection report listing 20 violations at the Fort Washington plant, also maintains that the recalled drugs pose a “remote” potential for serious health problems.

The House panel invited Johnson & Johnson Chief Executive William Weldon to testify but he declined to be present due to health reasons. The Committee said Colleen Goggins, worldwide chairman of Johnson & Johnson’s consumer group will testify at the hearings.

The FDA said Dr. Joshua Sharfstein, principal deputy Commissioner, Deborah Autor, Director of the office of compliance and Michael Chappell, acting commissioner for regulatory affairs, will testify on behalf of the agency.

Click here for the full report.

Europe Warned of Toyota Pedals Before U.S.

April 7, 2010

ABC News

By Ken Thomas and Larry Margasak

Long before Toyota told U.S. regulators about sticking accelerator pedals, the Japanese automaker warned its distributors throughout Europe about similar problems, documents obtained by The Associated Press show.

Concerns about sticking gas pedals and complaints from Toyota owners in the U.S. were rising at the end of 2009. The documents show that weeks earlier, on Sept. 29, its European division issued technical information “identifying a production improvement and repair procedure to address complaints by customers in those countries of sticking accelerator pedals, sudden rpm increase and/or sudden vehicle acceleration.”

Distributors throughout Europe and in Russia, Georgia, Kazakhstan, Turkey and Israel received the technical information.

In assessing a record $16.4 million fine on Toyota for failing to alert the U.S. government to the safety problems quickly enough, Transportation Secretary Ray LaHood cited the warnings to the other countries. LaHood said Tuesday that Toyota made a “huge mistake” by not disclosing the safety problems sooner.

The timeline in the documents shows that Toyota said in October it had received three reports of sticking pedals in Corollas sold in the United States. It notified the National Highway Traffic Safety Administration about the cases in November.

In November and December, Toyota engineers examined pedals from the Corollas and were able to replicate the sticking pedal problem in two of the three cases. The engineers “concluded that the phenomenon experienced in the United States was essentially the same as the phenomenon experienced in Europe,” the document said.

In mid-January, Toyota held internal meetings “to discuss status of production changes and to prepare for meetings with NHTSA” on Jan. 19, according to the timeline. Two days later, Toyota announced it would recall 2.3 million vehicles to address the sticking pedals.

The documents obtained by the AP were among 70,000 pages of papers turned over to government investigators. They show that on Sept. 29, the same day Toyota issued the repair procedures in Europe, the company told NHTSA of its decision to recall several Toyota and Lexus vehicle models “to address the risk of accelerator pedal entrapment by all-weather floor mats.”

Toyota has said the problems involved separate issues, and in the case of the sticking gas pedals, the problem was related to the buildup of condensation on sliding surfaces in the accelerator system that helps drivers push down or release the gas pedal.

The timelines, titled “preliminary chronology of principal events,” were provided to the government on March 24.

LaHood told reporters in Chicago on Tuesday that he wouldn’t be surprised if a review of documents from Toyota Motor Corp. uncovered additional safety lapses by the Japanese automaker.

“This is the first thing that we have found,” LaHood said. “It may not be the last thing.”

Under federal law, automakers must notify NHTSA within five days of determining that a safety defect exists and promptly conduct a recall.

Toyota, in a statement Tuesday, said it “has and will continue to practice its philosophy of satisfying consumers with high quality vehicles that are safe and reliable, and responding to consumer feedback with honesty and integrity.”

Toyota has recalled more than 6 million vehicles in the U.S. and a total of more than 8 million worldwide because of acceleration problems in multiple models and braking issues in the Prius hybrid.

The Japanese automaker was still weighing its options Tuesday about whether to accept or contest the fine. It has also been named in 138 potential class-action lawsuits over falling vehicle values and nearly 100 personal injury and wrongful death cases in federal courts.

Click here for the full report.

Baby Slings to Be Pulled From Market

March 24, 2010

Google News

By Associated Press

More than 1 million baby slings made by Infantino are being recalled because the products have been linked to three infant deaths.

The Consumer Product Safety Commission says babies can suffocate in the soft fabric slings. The agency is urging parents to immediately stop using the slings for babies under 4 months.

The recall involves 1 million Infantino “SlingRider” and “Wendy Bellissimo” slings in the United States and 15,000 in Canada. It follows a warning earlier this month from CPSC that sling-style baby carriers pose a suffocation risk to newborns.

Infantino President Jack Vresics (VREH’-siks) says the company will offer a free replacement baby carrier, activity gym or shopping cart cover to any affected consumer.

Click here for the full report.

Japanese Company Nipro Recalls 2 Million Medical Needles

January 27, 2010

AFP

Click here for the full report.