SigmaPharm Laboratories LLC has recalled approximately 15,052 bottles of Asenapine Sublingual Tablets (5 mg and 10 mg) because they were manufactured with the incorrect flavoring agent. The tablets were produced using artificial cherry flavor instead of the required artificial black cherry flavor. Consumers who use this prescription medication should continue to take their medicine but contact their healthcare provider or pharmacist regarding the substitution, as the medication was distributed nationwide in the US.
While this recall is classified as low risk, the product contains an incorrect flavoring agent not specified in the approved formulation, which may affect the taste or consumer experience.
Contact healthcare provider and return to pharmacy.
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Sources: FDA iRES · Raw API Response
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