JB Chemicals and Pharmaceuticals Ltd — Class II: Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Uniqu
JB Chemicals and Pharmaceuticals Ltd has initiated a Class II recall for Enalapril Maleate Tablets, USP, 20 mg (1,000-count bottles) due to failing impurity specifications. An Out of Specification (OOS) result was recorded during an Organic Impurities Test.
This recall affects manufacturers of generic antihypertensives, quality control laboratories, and distributors including Rising Pharma Holdings, Inc., as well as JB Chemicals and Pharmaceuticals Ltd.
A Class II recall indicates that the product may cause temporary or medically reversible adverse health consequences, although the probability of serious harm is remote. The failure to meet impurities and degradation specifications suggests potential issues in the manufacturing process or stability profile, which may necessitate a review of API sourcing or storage conditions to prevent future OOS occurrences.
QA and stability teams should review retention samples for potential degradation trends and ensure that impurity testing protocols are robust enough to detect OOS results before distribution. Regulatory teams should monitor the ongoing status of the recall and coordinate with distributors to ensure all affected lots are accounted for.
Class II. Reason: Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test. Product: 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.. Firm: JB Chemicals and Pharmaceuticals Ltd (Mumbai India). Status: Ongoing.
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