Dr. Reddy's Laboratories, Inc. has voluntarily recalled 4,800 bottles of Varenicline (1 mg) tablets, a prescription medication used to help adults quit smoking. The recall was issued because the tablets were found to be sub-potent during a 9-month stability test, meaning the level of active ingredient fell below the required specification. This lot was distributed nationwide in 54-count bottles.
Sub-potent medication may not provide the full therapeutic dose required, which could reduce the effectiveness of the treatment for patients trying to quit smoking. No injuries or adverse events have been reported to date.
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Quantity: 4800 54-count bottles
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Sources: FDA iRES · Raw API Response
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