The U.S. Food and Drug Administration (FDA) just announced that Neilgen Pharma Inc. of Westminster, Maryland and Advent Pharmaceutical of East Windsor, New Jersey have issued a recall for 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 products listed below due to the unapproved drug product category, said the FDA, which added that product safety and efficacy have not been established by the agency.
The FDA is advising consumers who are taking or in possession of the recalled cough and drug products to stop using them, return them to the place of purchase, and contact their physician or healthcare provider to obtain a replacement medication or prescription. Both Neilgen Pharma and Advent Pharma have stopped the production of these products and no injuries have been reported to date. The FDA states that patient exposure to the recalled products is not likely to cause adverse health consequences.
The FDA also explained that the action is precautionary and focused on removing the retail products at the retail level. All of the recalled products were distributed to wholesalers in Alabama and North Carolina and can be identified by name, description, and lot numbers, which are listed, below. The FDA said that inquiries should be addressed to Advent Pharma Customer Services, toll-free at 1-888-634-5522. A representative is available Monday through Friday, 8:00 a.m. to 5:00 p.m. EST.
Advent Pharmaceutical Recalled Products
- RY-Tann Caplets: Phenylephrine Tannate 25 mg/ Chlorpheniramine Tannate 9 mg Caplets; lot numbers 806009, 806010, and 806011.
- D-Tann CT Caplets: Diphenhydramine Tannate/Phenylephrine Tannate/ Carbetapentane Tannate 25/10/30 mg Caplets; lot numbers 806003 and 806004.
Neilgen Pharma Recalled Products
- D-Tann Suspension: Diphenhydramine Tannate/Phenylephrine Tannate 25/7.5 mg Suspension; lot numbers L08C192, L08D171, L08E121, and L08E131.
- D-Tann CT Suspension: Diphenhydramine Tannate/Phenylephrine Tannate/ Carbetapentane Tannate 25/10/30 mg Suspension; lot numbers L08C201, L08E071, and L08E091.
- Ben-Tann Suspension: Diphenhydramine Tannate 25 mg Suspension; lot numbers L08D032 and L08E061.
- D-Tann AT Suspension: Diphenhydramine Tannate/ Carbetapentane Tannate 25/30 mg Suspension; lot numbers L08E271 and L08E281.
- D-Tann CD Suspension: Diphenhydramine Tannate/ Phenylephrine Tannate/ Carbetapentane Tannate 25/15/30 mg Suspension; lot number L08F051.
- D-Tann DM Suspension: Diphenhydramine Tannate/ Phenylephrine Tannate/ Dextromethorphan Tannate 25/7.5/75 mg Suspension; lot numbers L08F121 and L08F131.
- B-Vex Suspension: Brompheniramine Tannate 12 mg Suspension; lot numbers L08D031, L08E021, and L08E051.
- B-Vex D Suspension: Brompheniramine Tannate/ Phenylephrine Tannate 12/20 mg Suspension; lot numbers L08D031 and 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; lot numbers L08C181 and 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; lot numbers L08D091, L08D223 L08E161, and L08F111.
- PE Tann 20 mg/ CP Tann 4 mg Suspension: Phenylephrine Tannate/ Chlorpheniramine Tannate 20/4 mg Suspension; lot numbers L08D222, L08E201, and L08F102.