The Ministery of Food and Drug Safety said on the 24th that Shin Poong Pharm voluntarily recalled its pediatric antibiotic Cramoxin Duo dry syrup recently. The product treats bronchitis, tonsillitis and sinusitis. It appears likely to affect the supply of winter cold antibiotics.
Cramoxin Duo dry syrup is a combination product of amoxicillin and potassium clavulanate used as a pediatric antibiotic. The Ministery of Food and Drug Safety said, "Biological equivalence was not demonstrated as a result of the drug re-evaluation."
Generic drugs go through bioequivalence tests to determine whether the efficacy and safety in humans are the same as the existing drug. If a generic's effect falls within a certain range through this process, it can receive approval from the Ministery of Food and Drug Safety and be released. The company reported that equivalence was not demonstrated and moved to voluntarily recall the product.