Raritan Pharmaceuticals, a manufacturer for Homeolab USA, is recalling homeopathic products containing belladonna extract because there is potential for variation in the content of belladonna extract. The FDA tested some of the products and found varying levels of belladonna from what is declared on the label.
Last month, the FDA warned consumers not to use homeopathic teething products for exactly this reason. Symptoms of belladonna toxicity include seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, and agitation.
The recalled products include CVS Homeopathic Infants’ Teething Tablet 135 tablets with UPC number 050428424162 and lot numbers 41116 and 43436. CVS has already taken a market action on this product as of September 30, 2016.
Also recalled is Kids Relief Homeopathic Ear Relief Oral Liquid in 0.85 ounce containers and lot number 35254. The UPC number for that product is 778159090639. Finally, CVS Homeopathic Kids’ Ear Relief Liquid in 0.85 ounce containers, with UPC number 050428441633 and lot 33149 is recalled. These products were distributed nationwide.
If you purchased any of these products, do not give them to your child. Return them to the place of purchase for a refund. If your child is experiencing any adverse reactions, they should see a doctor. Any adverse reactions can be reported to the FDA’s MedWatch Adverse Event Reporting Program.
