Hikma Pharmaceuticals USA INC. — Class II: Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Ca
Hikma Pharmaceuticals USA INC. initiated a Class II recall for specific lots of Ramipril Capsules USP, 10 mg, due to out-of-specification (OOS) results for the process impurity dicyclohexylurea (DCU). The affected products include 100-count and 500-count bottles manufactured by West-Ward Columbus Inc. for Exelan Pharmaceuticals, Inc.
This recall affects Hikma Pharmaceuticals USA INC., Exelan Pharmaceuticals, Inc., and West-Ward Columbus Inc., as well as pharmacists and distributors handling Ramipril Capsules USP, 10 mg under NDC 76282-673-01 and 76282-673-05.
The presence of dicyclohexylurea (DCU) as a process impurity suggests potential failures in the synthesis process or purification stages during manufacturing. A Class II designation indicates that while the health hazard is not likely to be immediate or life-threatening, the failure to meet degradation specifications necessitates market withdrawal to maintain regulatory compliance and product quality standards. Operations teams may need to investigate whether this is a localized batch issue or a broader process control concern.
Quality units should verify whether current analytical methods for ramipril or similar ACE inhibitors are sufficiently sensitive to detect DCU and review recent stability data for any upward trends in process impurities. Supply chain teams should confirm the status of NDC 76282-673-01 and 76282-673-05 in current inventory.
Class II. Reason: Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).. 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.. Firm: Hikma Pharmaceuticals USA INC. (Columbus OH United States). Status: Ongoing.
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