Posts Tagged ‘recall’

Recall of Brilliant Blue G Urgent Product Recall – Immediate Action Required

Sunday, March 25th, 2012

Contact:
Consumer:
Pharmacist-in-Charge
352-622-2913 ext. 209

Media:
Jim Kilbride, RPH
352-622-2913
Fax: 352-690-6770

March 9, 2012

Dear Physician:
Our records indicate that your office received Brilliant

Blue G compounded at Franck’s Lab. We have recently received reports that some patients treated with Brilliant Blue G have experienced fungal infections in the eye. The origin and cause of these eye infections has not yet been determined. The following lots of Brilliant Blue G are suspected of fungal contamination:

Lot Number:

  • 08232011@80
  • 10132011@6
  • 10112011@82
  • 10192011@125

As a precautionary measure and to prevent any additional risk of eye infections in patients, we are recalling all Brilliant Blue G compounded by Franck’s Lab. You are requested to immediately quarantine and return to us any remaining Brilliant Blue G product you may still have. This includes ALL LOTS of Brilliant Blue G that you have received from Franck’s Pharmacy. Our accounting department will issue credit on receipt of product.

Please complete the recall response form and return the product to the address below with the postage provided. If you would like to report any adverse events, or if you would like to receive additional information regarding this product recall, please contact us Monday through Friday, 8 a.m. to 5 p.m., at 352-622-2913 ext. 209 and request the Pharmacist-in-Charge.

Regards,
Jim Kilbride, RPh
Pharmacist-in-Charge
Franck’s Compounding disclaimer icon Lab
1210 SW 33rd Ave. Ocala, FL 34474
352-622-2913
Fax: 352-690-6770

Regeneca, Inc. Issues a Voluntary Nationwide Recall of All Lots of Single Capsule RegenErect Because of Potential Health Risks

Monday, March 5th, 2012

February, 2012 – (GLOBE NEWSWIRE) — Regeneca, Inc. (Pink Sheets:RGNA) announced today that it is conducting a voluntary nationwide recall of all lots of single capsule packet RegenErect, labeled as a dietary supplement. The company, through in

dependent lab analysis has confirmed the presence of Tadalafil making these products unapproved new drugs. Tadalafil is an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). The active drug ingredient is not listed on the label for these products.

Use of these products 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. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

Regeneca, Inc. has distributed RegenErect via sales made over the internet to consumers in the United States of America and Puerto Rico, and given as samples at public events.

RegenErect, is a blue capsule sold individually in foil packets with a UPC code of 816860010055. Regeneca, Inc. is committed to improving its products and avoiding future recall issues by improving its existing testing procedures.

Regeneca, Inc. advises any customers in possession of the RegenErect product above to return any unused product for an exchange, or a full refund, to the company directly. Customers can call (800) 690-6958 (Monday through Friday from 8am to 6pm Pacific Time) for instructions on the return and exchange/refund process. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

If you or anyone you know has been hurt by any Regeneca, inc product, call us at: 877 882 0095

For original article see: //www.fda.gov/Safety/Recalls/ucm293376.htm

Infant Tylenol Recalled

Monday, February 27th, 2012

74,000 bottles of infant Tylenol have been recalled by Johnson & Johnson’s McNeil Consumer Healthcare division.
A faulty part of the dosing system — an interior cap call

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ed a “flow restrictor” — can get pushed down into the bottle. This interferes with the syringe used to measure each dose. It could result in kids getting too much or too little acetaminophen, the painkiller/fever-reducer that is Tylenol’s active ingredient.
The recall affects seven lots of infants’ Tylenol Oral Suspension 1 oz. Grape, sold over the counter across the U.S. The recalled infant Tylenol:

  • Has the UPC code 300450122308
  • Has lot numbers BIL0U00, BIL0V00, BIL3500, BJL2D00, BJL2E00, BJL2T00, or BJL2U00

If you or anyone you know has been hurt by any Infant Tylenol, call us at 877 882 0095

Read more at the source: //www.webmd.com/parenting/baby/news/20120217/infant-tylenol-recalled

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Regeneca, Inc. Issues A Voluntary Nationwide Recall Of A Specific Lot Of RegenArouse Because Of Potential Health Risks

Thursday, February 16th, 2012

February 10, 2012 – Regeneca, Inc. announced today that it is conducting a voluntary nationwide recall of RegenArouse, Lot Number 130100, because FDA lab analysis has confirmed the presence of Tadalafil making these products unapproved new drugs.

Tadalafil is an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). The active drug ingredient is not listed on the label for these products.

Use of these products 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. FDA has advised that consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. FDA has advised that ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

Regeneca, Inc. has distributed RegenArouse via sales made over the internet to consumers in the United States of America and Puerto Rico between November 29, 2011 and February 10, 2012.

RegenArouse, Lot Number 130100, is a pink capsule sold individually in foil packets, with the expiration date of 12/5/2013 and a UPC code of 816860010079. Regeneca, Inc. had this specific lot of RegenArouse capsules tested at a testing facility and had received a report indicating that no PDE-5 inhibitors or any of their analogues were detected in the capsules. The Company learned today that there was an error on this test and has thus made the decision to issue a voluntary nationwide recall on this lot of RegenArouse. Regeneca, Inc. is committed to improving its products and avoiding future recall issues by improving its existing testing procedures.

Regeneca, Inc. advises any customers in possession of the RegenArouse product matching the lot number above to return any unused product for an exchange, or a full refund, to the company directly. Customers can call (800) 690-6958 (Monday through Friday from 8am to 6pm Pacific Time) for instructions on the return and exchange/refund process.

Any adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

If you or anyone you know has been hurt by any Regeneca, Inc. product, call us at: 877 882 0095

For original article see: //www.fda.gov/Safety/Recalls/ucm291546.htm

Halloween Projection Flashlights Recalled by Nygala Corp. Due to Fire and Burn Hazards

Wednesday, December 21st, 2011

WASHINGTON, D.C. – 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: Halloween Projection Flashlights

Units: About 10,000

Importer: Nygala Corp., of Teterboro, N.J.

Hazard: The flashlights can overheat, blister and melt, posing fire and burn hazards to consumers.

Incidents/Injuries: The firm has received one reported incident involving a flashlight that overheated, blistered and melted.

Description: The black and orange plastic flashlight is 6 � inches long and has pumpkins, bats, witches, haunted houses and cats on the handle. The flashlights come with six different plastic lenses that attach to the flashlight to project various images, including a pumpkin, bat, witch, haunted house and cat. The flashlights use two AA batteries. �Flomo,� �HW189� and UPC 677916518266 are printed on the packaging.

Sold at: Discount stores in California, Connecticut, Florida, Maryland, New Jersey, New York, Pennsylvania, Texas and Utah from August 2010 through October 2011 for about $1.

Manufactured in: China

Remedy: Consumers should immediately stop using the recalled flashlights, remove and properly discard the batteries and return the flashlights to the store where purchased for a full refund.

Consumer Contact: For additional information, contact Nygala Corp. at (800) 445-5936 between 9 a.m. and 5 p.m. ET Monday through Friday or visit the firm�s website www.flomousa.com

If you or anyone you know has been hurt by the Halloween projection flashlight, call us at: 877 882 0095

For original article see: //www.cpsc.gov/cpscpub/prerel/prhtml12/12051.html

CPSC Urges Consumers to Check Their Homes for Numerous Simplicity Nursery Product Recalls

Thursday, December 15th, 2011

Simplicity Inc. and SFCA Inc., the Reading, Pa.-based company that purchased the assets of juvenile product manufacturer Simplicity after foreclosure, are no longer in business. They are no longer answering phone calls, responding to e-mails from consumers, or providing repair kits to fix hundreds of thousands of defective cribs.

At least 13 children have tragically died in recalled Simplicity cribs and bassinets. CPSC is urging all parents, caregivers, online sellers and purchasers, daycare providers, and thrift store owners to immediately check if they have one of the following Simplicity-made or Simplicity-branded products and dispose of those units where there is no longer a remedy.

Date/Recall Product Name Model/Serial Numbers Remedy
Simplicity Crib Recalls
May 2005
05-164
White Lancaster Cribs 8554W-PT, 8554WW Remedy no longer available
Dec 2005
06-058
Graco Branded Aspen 3-in-1 Cribs 8740KCS SC/Serial Nos. 2803 SC to 1605 SC Retailer refund, replacement or store credit for cribs with metal mattress- support frames
June 2007
07-205
Nursery-in-a-Box Cribs 8910, 8050/Serial Nos. 3005Y to 0806 HY Retailer refund, replacement or store credit for cribs with metal mattress- support frames
Sept 2007
07-307
Aspen 3-in-1, Aspen 4-in-1, Nursery-in-a-Box, Crib N Changer Combo, Chelsea and Pooh 4-in-1, Graco-branded Aspen 3-in-1, Ultra 3-in-1, Ultra 4-in-1, Ultra 5-in-1, Whitney, Trio 4600, 4605, 4705, 5000, 8000, 8324, 8800, 8740, 8910, 8994, 8050, 8750, 8760, 8996 Drop side repair no longer available;
Retailer refund, replacement or store credit for cribs with metal mattress- support frames
Sept 2008
08-401
Aspen and Crib N Changer Combo, Gabrielle, Camille, Providence, Shenandoah 8620, 8745, 8748, 8755, 8756, 8778, 8810, 8994 Retailer refund, replacement or store credit
July 2009
09-260
Simplicity Drop Side Cribs Including but not limited to: 8050, 8325, 8620, 8745, 8748, 8755, 8756, 8765, 8778, 8810, 8994, 8995, 8996 Retailer refund, replacement, or store credit
April 2010
10-211
All Simplicity Cribs with tubular metal mattress-support frames All model numbers Retailer refund, replacement or store credit for cribs with metal mattress support frames
Simplicity Bassinet Recalls
Aug 2008
08-381
Simplicity 3-in-1 and 4-in-1 Convertible Bassinets Retailer refund or store credit
Sept 2008
08-396
Graco-branded Bassinets Sold between 2001 and 2004 Retailer refund or store credit
Sept 2008
08-396
Winnie the Pooh motif Bassinets Sold between 2002 and 2008 Retailer refund or store credit
Simplicity Play Yard Recalls
Jan 2009
09-098
Rainforest Portable Play Yards (made by Simplicity Inc. or SFCA Inc.) 5310 RNF, 5310RNFC, 5310RNFT, 5310RNFW Fisher Price replacing play yards
April 2009
09-187
Travel Tender Play Yards 5500DRM, 5500WDS, 5500FEL, 5501FEL, 5502MON, 5520PRO, 5550HAN, 5700MAN, 5750MIR Retailer refund or replacement

If there is no remedy available for a recalled Simplicity crib, parents and caregivers are advised to dispose of these cribs, even if it is believed that the hardware and drop side have been installed correctly. All of the recalled cribs have the potential to pose a danger to young children.

Consumers are urged to continue to contact CPSC at 800-638-2772 or info@cpsc.gov to report any incident or injury with a Simplicity brand product.

For more information on Crib Safety, visit CPSC’s Crib Information Center or read CPSC’s Crib blog Q&A.

For original article see: //www.cpsc.gov/cpscpub/prerel/prhtml09/09260list.html

Collective Brands Recalls KEDS Girls’ Shoes Due to Laceration Hazard

Wednesday, November 23rd, 2011

WASHINGTON, D.C. – 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: KEDS® “Know It All” Girls’ Shoe

Units: About 45,000

Importer/Distributor: Collective Brands, Inc., of Topeka, Kan.

Hazard: Ornamental stars on the heel of the shoe may loosen, posing a laceration hazard.

Incidents/Injuries: The firm has received 27 reports of cuts and scratches resulting from metal stars that loosened from the heel of the shoe.

Description: This recall involves KEDS® girls’ rubber soled shoes. The shoes are black and pink with white trim and a pink loop on the heel. “KEDS” appears on the tongue and heel of the shoe. The style number KY40098A is printed on the underside of the tongue. The shoes were sold in girls’ sizes 12 to 5.

Sold at: Various department stores and online retailers from June through October 2011 for about $23.

Manufactured in: China

Remedy: Consumers should take these shoes away from children immediately and contact Collective Brands to receive a gift card for $30 redeemable at Stride Rite stores or striderite.com.

If you or anyone you know has been hurt by the KEDS Girls’ Shoes, call us at 877 882 0095

//www.cpsc.gov/cpscpub/prerel/prhtml12/12045.html?tab=recalls

November 17, 2011 Update: encore100® Toric and encore100® Sphere Limited Lot Recall Q&As

Monday, November 21st, 2011

From the Cooper Vision Site:

encore100® Toric and encore100® Sphere Limited Lot Recall Q&As

Q: What is the cause of the encore100 Toric and encore100 Sphere recall?
A: The recall was initiated on limited lots of encore100 Toric and encore100 Sphere because
CooperVision identified certain lots that did not meet our updated quality requirements due to the
level of a residue (silicone oil).  The presence of the residue may cause hazy vision or discomfort,
severe eye pain or eye injuries requiring medical treatment. Not everyone experiences the same
symptoms.

Q: What happens if a contact lens wearer puts an impacted lens in their eye?

A: We have received complaint reports for the encore100 Toric lenses that began as hazy vision.
After the recall, some patient complaints were received that began as hazy vision but progressed to
severe eye pain or eye injuries requiring medical treatment.  Not every patient has the same
symptoms. Health and safety of patients are our top priority so the recall was expanded to the limited
lots of encore100 Sphere lenses.

Q: What should I do if I personally experience these symptoms?

A: Remove the lenses from your eyes immediately if you are currently wearing them. Contact your
eye care practitioner to let them know you are experiencing symptoms. Follow your eye care
practitioner’s instructions.

Q: If I have symptoms how long will they last?

A: If the lens is removed promptly after the onset of symptoms it likely will clear up within 15 to 30
minutes. If you leave the lens in your eye for a prolonged period of time the symptoms may progress
to a more serious condition. Contact your eye care practitioner to let them know you are
experiencing symptoms.

Q: Has anyone had permanent damage to their eye because of these symptoms?

A: To date we have not received any reports of permanent damage to a patient’s eye after wearing
the affected lens.

Q: What should be done with product that I currently have at home?

A: A small percentage of encore100 Toric and encore100 Sphere lenses are affected by this
situation. Please check the lot number on the carton or blister label you have by using the search
box on the www.coopervision.com/international-recalll website to see if your product has been
impacted by the recall, and if so, discontinue wear and return the lenses to your eye care
practitioner.  You may also call our Consumer Care hotline at 1-855-526-6737.

Q: Will I be able to re-order my encore100 Toric and encore100 Sphere lenses?

A: We expect that encore100 Toric will be available for ordering in the spring of 2012.  We anticipate
minimal disruption to availability of encore100 Sphere and you may continue to order through your
practitioner.

//coopervision.com/pv_obj_cache/pv_obj_id_B84970CE53ADAF9E19484A5FD2C6ABD949630000/filename/encore100_Toric_and_encore100_Sphere_Consumer_FAQs_v7.pdf

Bike Trailer Recall

Thursday, November 3rd, 2011

From the CPSC:

Units: About 2,700

Manufacturer: Weehoo Inc., of Golden, Colo.

Hazard: The receiver on the trailer’s seat post hitch can crack and cause the trailer to detach, posing fall and crash hazards.

Description: 2011 Weehoo iGo bicycle trailers manufactured between April and July 2011 have a steel frame with an adjustable seat for passengers 38 to 52 inches tall, two pedals with straps, an enclosed sprocket and chain, a 20-inch wheel, two pannier pockets, a flagpole and a flag. The seat, pannier pockets and flag are made of red, heavy-duty nylon.

Sold at: Bicycle retail stores nationwide from April to July 2011 for about $390.

If you or anyone you know has been hurt by the Weehoo Inc. Bike Trailer, call us at 877 882  0095

For original article see: //www.cpsc.gov/cpscpub/prerel/prhtml11/11323.html

Lilly pulls sepsis drug Xigris

Monday, October 31st, 2011

Eli Lilly and Co withdrew its sepsis drug Xigris from all markets after the product, deemed a potential big seller when it was approved a decade ago, failed to improve survival in a clinical trial.

Sepsis is a severe, often life-threatening illness caused by the immune system’s over-aggressive response to infections — releasing inflammatory proteins that cause shock and shut down multiple organs. The condition occurs in 1 to 2 percent of all hospitalizations in the United States.

Xigris, which has never reached its lofty initial sales projections, had global sales of about $100 million in 2010. It has garnered total sales of $1.5 billion since being approved in the United States in 2001 and in Europe the following year.

If you or anyone you know has been hurt by Xigris, call us at 877 882 0095

//www.reuters.com/article/2011/10/25/elililly-idUSN1E79O08320111025

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