FDARecalled Sep 2, 2026 · #D-0831-2026
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 ...
Hazard
Class II — temporary health risk
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Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU). Classification: Class II Distribution: Nationwide within the United States
Product details
- 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.
- Type
- Drugs
- Manufacturer
- Hikma Pharmaceuticals USA INC.
- Model numbers
- AC5470A, AC5470B
- UPCs
- —