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Showing posts with label cold. Show all posts
Showing posts with label cold. Show all posts

Monday, December 13, 2010

Reese Pharmaceutical Company Announces the Voluntary Nationwide Recall of Certain Over-The-Counter Cold Relief Products that are Mislabeled

Reese Pharmaceutical Company of Cleveland, Ohio has voluntarily recalled lot# 091612 only in 60-count size bottles identified under four different brand names, listed in the table below, because cold decongestant tablets (containing Acetaminophen 325 mg, Phenylephrine 5 mg & Chlorpheniramine Maleate 2 mg) were mislabeled as containing only 200mg Guaifenesin tablets. This mislabeling could cause a consumer to ingest the product and unknowingly be exposed to serious side effects of acetaminophen, phenylephrine or chlorpheniramine.

Product NameNDC#Lot#
Refenesen Expectorant (guaifenesin 200 mg tablets)10956-752-60;091612 05/11 SS/SCT36 06/26/09
Select Brand Mucus Relief Expectorant (guaifenesin 200 mg)15127-129-60091612 05/11 SS/SCT36 06/26/09
QC Medifin Expectorant (guaifenesin 200 mg)63868-754-60091612 05/11 SS/SCT36 06/26/09
Leader Cough Tabs Expectorant (guaifenesin 200 mg)37205-466-72091612 05/11 SS/SCT36 06/26/09

The mislabeled product does not warn consumers that Acetaminophen may cause liver damage. Ingesting high doses of Acetaminophen can potentially cause severe liver damage. The likelihood of acute liver damage is higher among consumers with pre-existing liver disease and those who drink three or more alcoholic drinks per day. Overdose may specially occur if consumers are also taking other cold/cough products that contain Acetaminophen in addition to the mislabeled product. Contraindications for Phenylephrine are high-blood pressure, poor blood flow to the extremities, and patients on antidepressants known as MAO Inhibitors. Furthermore, products that contain Phenylephrine should be used with caution in patients with high blood pressure, diabetes, heart disease, increased intraocular pressure, hyperthyroidism, or enlarged prostate. Consumers who are allergic to any of the ingredients or who have narrow angle glaucoma, or are pregnant or nursing mothers, also should not take the product. However, to date, there have been no reports of adverse events from its use.

This product was distributed nationwide. Consumers who have purchased the product ( lot # 091612 only) should contact Russ or Neal Slaby at 1.800.321.7178 between 7:30-4:00pm eastern standard time for return instructions, medical information, questions, complaints or assistance.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Notification of the recall has been sent to all customers who purchased this product directly from Reese Pharmaceutical Company.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

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Monday, November 29, 2010

Recall of Tylenol Cold Liquid Products

In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling, from the wholesale and retail level, three TYLENOL® Cold Multi-Symptom liquid products in order to update the labeling for these products. The specific products involved, listed below, are sold in the United States.

This is a wholesale and retail level recall and is not being undertaken on the basis of adverse events. No action is required by consumers or healthcare providers and consumers can continue to use the product.

McNeil Consumer Healthcare initiated the recall after an internal review revealed that information about the presence of alcohol from flavoring agents was noted as an inactive ingredient listed on the package, but not on the front panel of the product. Certain flavoring agents contribute small (<1%) amounts of alcohol.

Consumers with questions should call our Consumer Care Center at 1-888-222-6036 (available Monday-Friday from 8 a.m. - 8 p.m. ET and Saturday - Sunday, 9 a.m. - 5 p.m. Eastern Time.)

The NDC codes for the recalled products can be found on the product front panel.

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Sunday, January 17, 2010

Parkers Farm, Inc. Expands Recall to Include All of Its Products, Regardless of Code Dates, Because of Possible Health Risk

Parkers Farm, Inc. of Coon Rapids, Minnesota today expanded the previously announced recall of products to include all date codes because they have the potential to be contaminated with listeria monocytogenes, an organism which can cause serious and sometimes fatal infection in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term sympotms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.

No illnesses have been reported to date in connection with this problem.

The recall originally announced 01/08/2010 affected product with sell by dates of specific ranges. The expanded recall now includes all products and all sell by dates. The recalled products were distributed nationwide in the following retail stores: Hy-Vee, Cub, Rainbow, Byerlys, Lunds, Target, Whole Foods, Jewel, Dominicks, Marsh, Price Chopper, Shop Rite, Nash Finch, Sams Club, Costco, Safeway, Kroger, Wal-Mart, Aldi..

The following recalled products were sold under the Parker Farm or Parkers label:

~~~12 ounce & 16 ounce peanut butter in square plastic containers (tub with snap on lid), regular and organic varieties are creamy, crunchy, honey creamy and honey crunchy with sell by dates on or before 12/31/2010.

~~~34 ounce peanut butter in round plastic containers (tub with snap on lid), varieties are creamy and crunchy with sell by dates on or before 09/30/2010.

~~~7 ounce bagel spreads in white plastic containers (tub with snap on lid), varieties are garden veggie, wild berry, strawberry, apple cinnamon and honey walnut with sell by dates on or before 06/30/2010.

~~~12 ounce & 14 ounce dips & spreads in square plastic containers (tub with snap on lid), varities are jalapeno nacho, pimento and salsa con queso with sell by dates on or before 09/30/2010.

~~~8 ounce, 12 ounce and 16 ounce cold pack cheese in round or square plastic containers (tub with snap on lid), varieties are sharp cheddar, bacon, onion, smoked cheddar, Swiss almond, horseradish, garlic, port wine, and swiss & cheddar with sell by dates on or before 12/31/2010.

~~~16 ounce salsa in square plastic containers (tub with snap on lid), varieties are hot, mild, garlic, black bean and fire roasted with sell by dates on or before 04/30/2010.

~~~32 ounce salsa in plastic jugs (clear jug with screw cap), varieites are hot, mild, garlic, and black bean with sell by dates on or before 04/30/2010.

~~~128 ounce salsa in plastic jugs (clear jug with screw cap), varieites are hot, fire roasted, mild and garlic with sell by dates on or before 04/30/2010.

~~~8 ounce, 9 ounce, 10 ounce Balls & Logs (in film overwrap), varieties are sharp cheddar, port wine, smokey bacon, ranch, garlic, jalapeno, pimento, spinach, jajik, beer and chorizo with sell by dates on or before 01/05/2011.

~~~5#, 5.5#, 10#, 30# Parker Farm cold pack cheese (white tub with snap on lid), varieties are sharp cheddar, onion, bacon, smoked cheddar, swiss almond, horseradish, garlic, port wine, and swiss & cheddar with sell by dates on or before 09/30/2010.

Other labels affected by this recall:

~~~16 ounce Happy Farms cold pack cheese in round plastic containers (tub with snap on lid), varieties are sharp cheddar, port wine and swiss almond with sell by dates on or before 12/31/2010.

~~~8 ounce Kroger cold pack cheese in round plastic containers (tub with snap on lid), varieties are sharp cheddar, port wine and swiss almond with sell by dates on or before 12/31/2010.

~~~8 ounce Central Markets cold pack cheese in round plastic containers (tub with snap on lid), varieties are sharp cheddar, port wine, swiss almond, horseradish with sell by dates on or before 12/31/2010.

~~~14 ounce Central Markets salsa con queso in round plastic containers (tub with snap on lid) with sell by dates on or before 09/30/2010.

~~~16 ounce Central Markets salsa in round plastic containers (tub with snap on lid), varieties are sharp cheddar, port wine, swiss almond, horseradish with sell by dates on or before 04/30/2010.

~~~8 ounce Dutch Farms cold pack cheese in round plastic containers (tub with snap on lid), varieties are sharp cheddar, port wine, swiss almond, horseradish, and swiss & cheddar with sell by dates on or before 12/31/2010.

~~~7 ounce Dutch Farms cream cheese spreads in round plastic containers (tub with snap on lid), varieties are strawberry, wild berry, honey walnut & apple cinnamon with sell by dates on or before 06/30/2010.

~~~8 ounce Crystal Farms cold pack cheese in round plastic containers (tub with snap on lid), varieties are sharp cheddar, port wine, swiss almond, bacon and jalapeno cheddar with sell by dates on or before 12/31/2010.

~~~8 ounce Heluva Good cold pack cheese in round plastic containers (tub with snap on lid), varieties are sharp cheddar, port wine and horseradish cheddar with sell by dates on or before 12/31/2010.

~~~8 ounce Amish Classic cold pack cheese in round plastic containers (tub with snap on lid), varieites are sharp cheddar, port wine, swiss almond, horseradish with sell by dates on or before 12/31/2010.

~~~10 ounce Amish Classic cheese balls & logs (in film overwrap), varieties are cheddar, port wine, ranch, smokey bacon, beef n onion with sell by dates on or before 01/05/2011.

~~~128 ounce San Pablo salsa in plastic jugs (clear jug with screw cap), varieites are fire roasted and mild with sell by dates on or before 04/30/2010.

~~~12 ounce Century Resources cold pack cheese food (tub with snap on lid), varieties are sharp cheddar, horserdish, bacon with a sell by date of xxx9 (the first 3 digits aren’t important, but the last digit must be a 9)

~~~12 ounce Century Resources pimento spread (tub with snap on lid) with a sell by date of xxx9 (the first 3 digits aren’t important, but the last digit must be a 9.

~~~8 ounce and 12/12 ounce Century Resources cheese ball & log (in film overwrap) sharp cheddar with a sell by date of xxx9 (the first 3 digits aren’t important, but the last digit must be a 9)

~~~12 ounce Century Resources salsa con queso (tub with snap on lid) with a sell by date of xxx9 (the first 3 digits aren’t important, but the last digit must be a 9)

~~~4#, 5.5# Block & Barrel cold pack cheese (white tub with snap on lid), varieties are sharp cheddar, swiss almond, horseradish, port wine and pimiento spread with packed on dates on or before 12/30/2009.

~~~30# Block & Barrel sharp cheddar cold pack cheese (white pail with snap on lid) with packed on dates on or before 12/30/2009..

~~~5# Cobblestone cold pack cheese (white tub with snap on lid), varieties are sharp cheddar, port wine, swiss almond, horseradish with sell by dates on or before 06/30/2010.

~~~30# Cobblestone sharp cheddar cold pack cheese (white pail with snap on lid) with sell by dates on or before 06/30/2010.

~~~5# Biery label cold pack cheese (white tub with snap on lid), varieties are sharp cheddar and port wine with sell by dates on or before 09/30/2010.

~~~~~~5# Dierks Waukesha cold pack cheese (white tub with snap on lid), varieties are sharp cheddar, port wine, horseradish, swiss almond with sell by dates on or before 09/30/2010.

The recall was a result of a sampling done by the state of Wisconsin and the state of Minnesota which revealed that some finished products contained the bacteria. The state of Minneosta, FDA, and the company continue their investigation as to what caused the problem. No illnesses have been reported to date in connection with this problem.

Consumers who have purchased these products are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at (800) 869-6685.

For the ultimate safety of our customer and in order to create less confusion for them, Parkers Farm, Inc. Has decided to include all of its products, regardless of date codes in this recall.

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Tuesday, April 21, 2009

Neilgen Pharma Inc. and Advent Pharmaceutical Recall All Prescription Cough and Cold Drug Products Sold on or after March 5, 2008

Neilgen Pharma Inc. of Westminster, MD and Advent Pharmaceutical of East Windsor, NJ are recalling all prescription cough and cold drug products sold on or after March 5, 2008. Neilgen Pharma and Advent Pharmaceutical are contract manufacturers for these products and are recalling the listed products below due to the unapproved drug product category.

Consumers taking these recall products which is being recalled should stop using and return product to place of purchase and contact their physician or healthcare provider to obtain a replacement medication or prescription.

Safety and effectiveness have not been established by FDA. However, patient exposure to affected products is not likely to cause adverse health consequences. Both Neilgen Pharma and Advent Pharma have stopped the production of these products and no injuries have been reported to date.

This precautionary action is focused on removing products to the retail level only. FDA has been apprised of this action. All of the products under recall were distributed to wholesalers located in Alabama and North Carolina.

The drug products can be identified by provided name, description and lot numbers.

Inquiries related to this recall should be addressed to Advent Pharma Customer Services at 1-888-634-5522. Representative is available Monday through Friday, 8 a.m. to 5 p.m. EST.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's Adverse Event Reporting program either online, by regular mail or by fax.

This recall includes all lots manufactured/distributed on or after March 5, 2008 within expiration date of the product listed below.

Advent Pharma Recalled Products

Name

Product Description

Lot Number

RY-Tann
Caplets

Phenylephrine Tannate 25 mg/ Chlorpheniramine Tannate 9 mg Caplets

806009, 806010,
806011

D-Tann CT
Caplets

Diphenhydramine Tannate/Phenylephrine Tannate/ Carbetapentane Tannate
25/10/30 mg Caplets

806003, 806004

Neilgen Pharma Recalled Products

Name

Product Description

Lot Number

D-Tann Suspension

Diphenhydramine Tannate/Phenylephrine Tannate 25/7.5 mg Suspension

L08C192, L08D171, L08E121, L08E131,

D-Tann CT
Suspension

Diphenhydramine Tannate/Phenylephrine Tannate/ Carbetapentane Tannate
25/10/30 mg Suspension

L08C201, L08E071,
L08E091

Ben-Tann
Suspension

Diphenhydramine Tannate 25 mg Suspension

L08D032, L08E061

D-Tann AT
Suspension

Diphenhydramine Tannate/ Carbetapentane Tannate 25/30 mg Suspension

L08E271, L08E281

D-Tann CD
Suspension

Diphenhydramine Tannate/ Phenylephrine Tannate/
Carbetapentane Tannate 25/15/30 mg Suspension

L08F051

D-Tann DM
Suspension

Diphenhydramine Tannate/ Phenylephrine Tannate/
Dextromethorphan Tannate 25/7.5/75 mg Suspension

L08F121, L08F131

B-Vex
Suspension

Brompheniramine Tannate 12 mg Suspension

L08D031, L08E021,
L08E051

B-Vex D
Suspension

Brompheniramine Tannate/ Phenylephrine Tannate 12/20 mg Suspension

L08D031, L08D181

BROM TANN
8 mg/DM TANN
60 mg/PSE TANN
90 mg Suspension

Brompheniramine Tannate/ Dextromethorphan Tannate/
Pseudoephedrine Tannate 8/60/90 mg Suspension

L08C181, L08D041

DM Tann
30 mg/ PE Tann/25
mg Brom Tann
10 mg Suspension

Dextromethorphan Tannate/ Phenylephrine Tannate/
Brompheniramine Tannate 30/25/10 mg Suspension

L08D091, L08D223
L08E161, L08F111

PE Tann 20 mg/
CP Tann 4 mg
Suspension

Phenylephrine Tannate/ Chlorpheniramine Tannate 20/4 mg Suspension

L08D222, L08E201
L08F102




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