Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 C…
Official notice from a government agency or its published feed.
Reason: Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · Nationwide within the United States
Hazard: Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
View the FDA enforcement report ↗ ← All reports