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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