Class II recall: Hikma Pharmaceuticals USA INC.: Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and

Hikma Pharmaceuticals USA (via Exelan Pharmaceuticals) issued a Class II recall of Ramipril Capsules USP, 10 mg, in 100-capsule (NDC 76282-673-01) and 500-capsule (NDC 76282-673-05) bottles. According to the recall notice, the action was prompted by an out-of-specification result for the process impurity dicyclohexylurea (DCU) found during impurities and degradation testing. The product was manufactured by West-Ward Columbus Inc. for Exelan Pharmaceuticals.

Most relevant for: patients taking ramipril 10 mg capsules from the affected Hikma Pharmaceuticals batches who may have been exposed to elevated levels of the process impurity dicyclohexylurea

Summary written by an AI model from the source text and dated by the source's publication date. Check the original before acting on it. How MedFollow selects and summarizes updates.

Informational only. Not medical advice. Not a substitute for clinical judgment. Always consult current guidelines and your own clinical judgment.