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BALTIMORE (April 4, 2012) – The Department of Health and Mental Hygiene (DHMH) today issued an alert regarding the use of an unapproved medicine called Baczol, which contains an antibiotic that would ordinarily require a prescription and is ineffective against some of the conditions for which it is commonly purchased. This unapproved medicine, which is produced outside the United States, has been found in a number of convenience stores that serve Latino communities and is marketed specifically for pediatric populations under the names Baczol, Pediatric Baczol, or Baczol Antigripal. The U.S. Food and Drug Administration has issued an import alert for this medication (Import Alert # 66-41, 2/7/2011).

Concern about this medication was raised when a clinician at the Bayview Medical Center in Baltimore heard from several Hispanic families that they were purchasing from local Latino convenient stores an over the counter “cold medication” and giving it to their children. The clinician became concerned about the medication and recognized that it represented a potential hazard to young children. She contacted the Baltimore City Health Department, which investigated local Latino convenience stores and found Baczol for sale in three of them. A further investigation revealed that the product is available for sale in other locations in Maryland.

“Unapproved medications represent a serious danger to patients,” said Dr. Joshua M. Sharfstein, Secretary of DHMH. “Prompt reporting by this very alert clinician has potentially saved lives.”

Consumers who are already using this product should consult their health care provider. The Department recommends that health care providers ask patients whether they have used or are using this product. If so, providers are urged to recommend that their patients discontinue use of the product. In addition, providers or others who are aware that the product is for sale are urged to contact their local health department.

"We hope providers statewide will take care to warn parents about the potential dangers associated with unapproved, unregulated medications like this one," said Dr. Laura Herrera, Chief Medical Officer at DHMH.



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