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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

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

 

Contact:
Bharat Patel, President
(609) 448-5500

 

FOR IMMEDIATE RELEASE -- April 20, 2009 -- 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 shouldstop 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 Caplets806009, 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 SuspensionDiphenhydramine Tannate/Phenylephrine Tannate 25/7.5 mg SuspensionL08C192, 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 SuspensionL08D032, L08E061
D-Tann AT
Suspension
Diphenhydramine Tannate/ Carbetapentane Tannate 25/30 mg SuspensionL08E271, 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 SuspensionL08D031, L08E021,
L08E051
B-Vex D
Suspension
Brompheniramine Tannate/ Phenylephrine Tannate 12/20 mg SuspensionL08D031, 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 SuspensionL08D222, L08E201
L08F102

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