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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1179-2022 |
| Event ID | 89863 |
| Brand | ENALAPRIL MALEATE |
| Generic Name | ENALAPRIL MALEATE |
| Manufacturer | ENALAPRIL MALEATE |
| Active Substance | ENALAPRIL MALEATE |
| Drug Route | ORAL |
| Distribution | Nationwide in the U.S: PA, MA, OH, TX, IL, ND, HI |
| Quantity | 31,260 bottles |
| Recall Reason | CGMP Deviations |
| Drug Classification | Class II |
| Drug Code Info | 20220713 |
| Product NDC | 60429-183 60429-184 60429-185 |
| Recall Initiation Date | 20220316 |
| Report Date | 20220713 |
| Classification Date | 20220707 |
| Address | 5187 Camino Ruiz Camarillo, CA 93012-8601 United States |
| Recalling Firm | Golden State Medical Supply Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Unique Ingredient Identifier | 9O25354EPJ |
| Drug Application Number | ANDA075657 |
| 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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