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ENALAPRIL MALEATE Recall D-1179-2022

Description: Enalapril Maleate Tablets, USP; 10 mg; 90 tablets, NDC 60429-185-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.

ENALAPRIL MALEATE Recall D-1179-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1179-2022
Event ID89863
BrandENALAPRIL MALEATE
Generic NameENALAPRIL MALEATE
ManufacturerENALAPRIL MALEATE
Active SubstanceENALAPRIL MALEATE
Drug RouteORAL
DistributionNationwide in the U.S: PA, MA, OH, TX, IL, ND, HI
Quantity31,260 bottles
Recall ReasonCGMP Deviations
Drug ClassificationClass II
Drug Code Info20220713
Product NDC60429-183 60429-184 60429-185
Recall Initiation Date20220316
Report Date20220713
Classification Date20220707
Address5187 Camino Ruiz
Camarillo, CA 93012-8601
United States
Recalling FirmGolden State Medical Supply Inc.
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Unique Ingredient Identifier9O25354EPJ
Drug Application NumberANDA075657
Structured Product Labeling (SPL ID)b7a23dd6-e7b8-0a56-e053-2995a90a50e3
Structured Product Labeling (SPL Set ID)0a12343f-5733-40cc-93b4-a02f5147fb91
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