Warning
JB Chemicals and Pharmaceuticals Ltd Recalls Enalapril Maleate Tablets
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0520-2026Drug / Pharmaceutical
JB Chemicals and Pharmaceuticals Ltd Recalls Enalapril Maleate Tablets
JB Chemicals and Pharmaceuticals Ltd · Class II — Moderate Risk
Product Description
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 for Recall
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Nationwide in the USA
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database