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
22 FDA recalls mention Enalapril. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Enalapril.
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
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Reason Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Reason Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Reason Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to…
Reason Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to…
Reason Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant
Reason Failed Impurities/Degradation Specifications
Reason Failed Impurities/Degradation Specifications
Reason Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related…
Reason Failed Stability Specifications
Reason Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
Reason Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.
Reason Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset
Reason Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength.
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