Ramipril Capsules USP, 10 mg
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.
Why it was recalled
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
What to do
The recall is ongoing. Follow the firm and FDA instructions.
Affected products and identifiers
a) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027 — a) 25,970 bottles; b) 2,384 bottles
Record details
Hikma Pharmaceuticals USA INC. — Nationwide within the United States