Large Cold Medication Recall. 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 […]
Large Cold Medication Recall. 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
Neilgen Pharma Recalled Products
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