Raritan Pharmaceuticals, a contract manufacturer for Homeolab USA, is voluntarily recalling homeopathic products containing belladonna extract (see products below) due to the potential for variation in the content of belladonna extract in the products. The U.S. FDA has tested some products and recovered varying levels of belladonna extract content from what is declared on the label. Raritan Pharmaceuticals is a contract manufacturer of these products for Homeolab USA that supplies the belladonna blends to Raritan Pharmaceuticals.
Product: CVS Homeopathic Infants’ Teething Tablet 135 tablets
(Please note that CVS has already taken a market action on this product as of September 30, 2016) Lots: 41116 and 43436
Product: Kids Relief Homeopathic Ear Relief Oral Liquid 0.85 fl. oz. Lot: 35254
Product: CVS Homeopathic Kids’ Ear Relief Liquid 0.85 fl. oz. Lot: 33149
The homeopathic products have a very small amount of belladonna, a substance that can cause harm at larger doses. The company is voluntarily recalling the product out of an abundance of caution.
These products were distributed Nationwide. Consumers with any product being recalled should stop using the product. Consumers with questions regarding this recall can contact Raritan Pharmaceuticals by phone at 1-866-467-2748 (Monday-Friday from 8am to 5:30pm EST).
No other Homeolab or Raritan products are affected.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program:
Complete and submit the report online at www.fda.gov/medwatch/report.htm or
Download and complete the form, then submit it via fax at 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.