Raritan Pharmaceuticals announced a voluntary recall of several homeopathic products due to the potential for variation in the content of belladonna extract.
The Food and Drug Administration (FDA) tested some of Raritan’s belladonna extract containing products and found that the levels of the extract varied to what was declared on the label. In general, the amount of belladonna in these products is very small, however, the company is recalling the products out of an abundance of caution.
The specific product and lot numbers affected include:
- CVS Homeopathic Infants’ Teething Tablet 135 tablets, UPC: 050428424162, Lots: 41116 and 43436
- Kids Relief Homeopathic Ear Relief Oral Liquid 0.85 fl. oz., UPC: 778159090639, Lot: 35254
- CVS Homeopathic Kids’ Ear Relief Liquid 0.85 fl. oz., UPC: 050428441633, Lot: 33149
Raritan Pharmaceuticals is a contract manufacturer of these products for Homeolab USA that supplies the belladonna blends to Raritan.
Belladonna alkaloids have anticholinergic properties which can be harmful at large doses. Signs of anticholinergic toxicity can include dry mouth, skin flushing, constipation, and decreased urination; drowsiness may also occur in infants.
In October 2016, the FDA issued a warning regarding homeopathic teething tablets and gels, recommending that consumers stop using them because of the possible inconsistency in the amount of belladonna extract found in these products.
Adverse events or side effects related to the use of these products should be reported to the FDA’s Medwatch Safety Information and Adverse Event Report Program.
For more information visit FDA.gov.