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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