Raritan Pharmaceuticals has issued a voluntary recall of some belladonna products sold in the market on Nov. 24, according to a report from FDA.
Raritan Pharmaceuticals, a contract manufacturer for Homeolab USA has issued this voluntarily recall on account of potential variation in the amount of belladonna extract present in the products. It is reported that the amount of extract present in the content did not match the quantity mentioned on the product label.
Raritan Pharmaceuticals Recalls Belladonna Products
"The products were distributed Nationwide: 1) Product: CVS Homeopathic Infants' Teething Tablet 135 tablets, UPC: 050428424162, Lots: 41116 and 43436; 2) Product: Kids Relief Homeopathic Ear Relief Oral Liquid 0.85 fl. oz., UPC: 778159090639, Lot: 35254 3) Product: CVS Homeopathic Kids' Ear Relief Liquid 0.85 fl. oz., UPC: 050428441633, Lot: 33149," read the FDA press release.
The FDA has cautioned that customers who bought these products should stop using them immediately. Consumers are also recommended to consult their doctors in case any adverse effects are experienced. Patients and healthcare officials may report the problems associated with the products to Adverse Event Reporting Program and FDA's MedWatch Safety Information.
What Is Belladonna?
Belladonna is a plant and the leaves and berries of which are used for medicinal purposes. Belladonna literally means "beautiful lady" and it is named after a risky practice followed in Italy. The extract from belladonna berries were used to enlarge the pupil of eyes in women for a beautiful and appealing look. This practice wasn't considered an ideal one as the potentially toxic extract may ruin the eyes.
Though Belladonna extract is regarded toxic in nature, it is still used by people around the world to treat a number of ailments including irritable bowel syndrome, spastic bladder, renal and biliary colic, colitis, peptic ulcer, infant colic and diverticulitis, reported WebMD.
Belladonna is also used to treat sweating, excessive salivation, rigidity and tremor caused as a result of Parkinson's disease. It is also used in the treatment of menstrual cramps, motion sickness, vomiting and nausea.
However people with kidney disease, myasthenia gravis, glaucoma, urinary tract blockage, blockage in intestines, ulcerative colitis complicated by toxic megacolon and severe ulcerative colitis are not advised to use Belladonna products.
Side Effects Of Belladonna
The side effects of Belladonna include irregular heart rate, difficulty in urination, headache, lightheadedness, dizziness, constipation, eye pain, rash or flushing, decreased sweating, weakness or nervousness, changes in taste, stuffiness, dry mouth, nasal congestion and allergic reaction like closing of throat, swelling of face, lips or tongue.
People are advised to seek immediate medical attention in case of such symptoms.