Hikma Pharmaceuticals USA INC.: Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282…
| Source | FDA · Drugs (US) |
|---|---|
| Date | 2026-09-02 |
| Product | Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33432, Manufactured by: West-Ward Columbus Inc., Columbus, OH 43228. |
| Reason / hazard | Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU). |
| Classification | Class II |
| Official notice | — |
| Record ID | fda-drug:D-0831-2026 |