Drug major Dr. Reddy’s Laboratories Inc. (the US subsidiary of Dr. Reddy’s), initiated a recall of Acid Controller tablets.
The tablets relieves heartburn associated with acid indigestion and sour stomach and as well prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages.
An action basically taken to remove the particular product from the market can be done by either the company itself or by the FDA under its own statutory authority. In this case, it is a Voluntary recall initiated by the company itself.
The recall has been initiated in the US alone and has been classified as a Class III recall which means the exposure to this recalled product is not likely to cause adverse health consequences.
The products were labelled and distributed by CVS pharmacy (CVS pharmacy OriginalStrength Acid Controller tablets, 10 mg, 30-count bottle, OTC) . The batches recalled has an expiry date of May, 2017. The recall has been initiated since 22-Apr-16.
While not all details have been divulged by the company or the FDA, the simple reason stated is “Failed impurities/degradation specification: An out of specification results has been determined for an individual related substance during stability testing at the 18th month interval for the Famotidine 10 mg Tablet, USP.”
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