Aceto US, L.L.C is recalling Actylis brand Lithium Orotate 4% and Lithium Orotate 9% because the products contain lower concentrations of the active ingredient than listed on the label. The 4% product may only contain 3% lithium orotate, while the 9% product may contain only 4.45%. This recall involves approximately 6,033.45 kg of the 9% product and 4,485.95 kg of the 4% product, which are sold in 25kg cartons containing HDPE liners. Consumers who use these products may not be receiving the intended dosage.
The products contain significantly less lithium orotate than labeled, which may prevent the user from receiving the expected therapeutic effect or dose. No illnesses or injuries have been reported to date in connection with this issue.
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Sources: FDA iRES · Raw API Response
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