Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div…
Reason Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Enalapril Maleate Tablets, USP 2.5 mg 100 tablets Rx only Distributed by: Cardinal Health, NDC 64679-923-02
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
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