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The antibiotic product, called Minocycline Nasal, is not FDA-approved and has been recalled in some states, the agency said. It contains 0.5 percent minocycline.
The full recall, which affects 2.1 million bottles, started Wednesday.
Medipren Inc., the maker of Minocycline Nasal, has not issued a recall notification to customers, according to the FDA.
Baker-Lilly said it was initiating the recall after receiving a notification Thursday from Health Canada, the agency that regulates all of Canada’s pharmaceutical and medical products.
“At this time, there have been no reports of adverse events associated with use of the recalled product,” the company said in a statement. “However, as this product is not FDA-approved, the Food and Drug Administration is taking this step to ensure patient safety.”
The products were distributed to retail and commercial pharmacies throughout the United States and the recall does not affect any consumers, according to the FDA.
But FDA officials said that customers should be cautious about purchasing any antibiotic nasal spray.
“Consumers are advised not to use this product, as it is not FDA-approved, and it is not known whether it is safe to use,” the agency said. “Consumers who have purchased this product and have concerns about using it should discard it immediately. For more information, the public can contact the firm from which they purchased the product by calling toll-free 1-888-280-9689 between 8 a.m. and 8 p.m. ET, or emailing the firm at minocycl
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