Raritan Pharmaceuticals Inc. Issues a Voluntary Nationwide Recall of Products Containing Belladonna Extract Due to the Possibility of the Presence of Belladonna Alkaloids
Released by Sushant Pradhan, Raritan Pharmaceuticals
On November 24, 2016, Raritan Pharmaceuticals, a contract manufacturer for Homeolab USA, issued a voluntarily recall of homeopathic products containing belladonna extract — due to the potential for variation in the content of belladonna extract in the products.
The US 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.
- UPC: 050428424162
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
- UPC: 778159090639
Product: Kids Relief Homeopathic Ear Relief Oral Liquid 0.85 fl. oz. Lot: 35254
- UPC: 050428441633
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 US Food and Drug Administration.