PAI Holdings, LLC (Pharmaceutical Associates Inc) is recalling approximately 13,480 unit dose cups of Citalopram Oral Solution, USP 20 mg/10 mL. This prescription antidepressant, also known by the brand name Celexa, is being recalled because the medication failed to meet impurity and degradation standards during a nine-month stability check. This means the chemical composition of the drug has changed over time, potentially affecting its quality and potency. This recall affects six specific lot numbers distributed nationwide.
The drug failed stability testing due to high out-of-specification results for impurities and degradation. Taking a medication that has degraded or contains higher than intended impurities may lead to a decrease in the drug's effectiveness or unintended side effects, though the current risk level is categorized as low.
Return unused product for a refund.
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Sources: FDA iRES · Raw API Response
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