Enalapril Maleate Tablets, USP recall — FDA D-1179-2022
CGMP Deviations
Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
10,685 detailed records are currently available in this category.
CGMP Deviations
CGMP Deviations
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Microbial Contamination of a Non-Sterile Products: Testing of product onfirmed the presence of Gluconacetobacter Liquefaciens
CGMP Deviations
Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
Defective Container
Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain microbial contamination identified as Providencia rettgeri.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer.
Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain elevated levels of yeast and mold as well as the presence of Bacillus cereus.
Defective Delivery System: Potential defect that could prevent the product from dispensing as intended.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification…
Defective Container: Product may leak when squeezed or when not in an upright position determined to be due to defects in the bottle neck finish and insufficient tightening.
Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
Failed Tablet/Capsule Specification; oversized tablet found in a bottle
Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.
Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.
Lack of assurance of sterility
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