Adams Respiratory Thereapeutics is initiating a voluntary retail level recall of specific lots of the above products. Following the launch of thease products in August 2006, Adams was made aware that the tablespoon markings on the closing cup which accompanied the subject lots had in rare instances been confused with the teaspoon markings on the cup resulting in the possibility of a dosing error. All other aspects of the product including the bottle and liquid remained safe and effective. The dosage instructions provided on the product labeling were also in full compliance. While Adams replaced the dosing cup on all product manufactured after November 21, 2006, it is now voluntarily recalling the earlier lots to eliminate any potential for consumer confusion to which the original closing cup may have contributed. No other lot numbers are involved in theis recall. this recall is being made with the knoledge of the Food and Drug Administration.
Disposition:
Please examine your inventory for the affected items completely and stop dispensing immediately. If you have any of the affected lot numbers, using your Telxon or Econolink, please transmit a request for return authorization as unsaleable, manufacturer recall, and return within 30 days to your McKesson servicing distribution center for credit.
NOTE: For All Recalled Product Not In Original Containers: Please note NDC#, Lot#, expiration date on the outside of the container for all product being returned that is not in the original manufacturer container. Any product received without this information will be returned to the customer without being processed.
If you have any questions, please call (800) 287-1584.
(Information contained in this document was provided by Adams Respiratory Therapeutics.)
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