Champaklal Maganlal Homeo Pharmacy Private Limited
FDA issued a warning letter to Champaklal Maganlal Homeo Pharmacy Private Limited (India) and its U.S. distributor Pharmadel, LLC/CAD Import, Inc. for manufacturing and distributing 'Bebelyn Diarrhea' and 'Bebelyn Colic' — homeopathic drug products marketed for infants and young children — without FDA approval. The products were found to be unapproved new drugs under section 505(a) of the FD&C Act, and the manufacturer had previously been cited for CGMP violations including failure to adequately test glycerin for diethylene glycol contamination, a known lethal hazard. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (7)
Bebelyn Drops Diarrhea temporarily relieves the symptoms of acute gastrointestinal distress associated with nonspecific diarrhea.
Bebelyn temporarily relieves the symptoms of acute gastrointestinal distress associated with nonspecific diarrhea
Bebelyn Colics [sic] . . . Relief: Cramps[,] Bloating[, and] Abdominal pain
Bebelyn Colic temporarily relieves the symptoms associated with colic. intestinal gas; bloating; cramping pains; hiccups.
Bebelyn provides your consumers with newborn care items they can rely on. From everyday use wipes to homeopathic pain treatment medicines. Bebelyn can give the comfort you seek if your child is suffering from colic or diarrhea caused by an upset stomach. Our all-natural formulas are the fast-acting answers you've been looking for.
Bebelyn Diarrhea . . . Relief: Diarrhea[,] Nausea[, and] Vomiting
Bebelyn temporarily relieves the symptoms associated with colic . . . intestinal gas[,] bloating[,] cramping pains[, and] hiccups
Required actions (2)
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct these violations.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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