Unichem Pharmaceuticals USA Inc. is recalling approximately 10,875 bottles of busPIRone Hydrochloride (5 mg) tablets because the medication may be subpotent. A subpotent drug means the tablets do not contain the full required amount of the active ingredient, which can lead to the medication being less effective than intended. These prescription tablets were distributed nationwide in 500-count bottles with an expiration date of December 2027.
The drug is subpotent, meaning it may not provide the full therapeutic dose needed to treat the patient's condition, potentially resulting in ineffective treatment of anxiety symptoms.
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Manufactured by Unichem Laboratories LTD. in India for Unichem Pharmaceuticals (USA), Inc.
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Sources: FDA iRES · Raw API Response
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