Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 64980-688-10.
Reason
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
Classification
Class II
Status
Ongoing
Lot
Lot #: GEH25023, Expires: 6/30/2027
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
JB Chemicals and Pharmaceuticals Ltd — Class II Recall | MedicineWatch US