D-0074-2018 Class III Terminated
FDA drug recall D-0074-2018 was initiated by Amerisource Health Services on August 29, 2017 and is designated Class III. Reason for recall: Failed Stability Specifications The recall status is terminated (terminated August 21, 2019). Affected quantity: 93,600 tablets.
Recall Details
- Product Type
- Drugs
- Report Date
- November 22, 2017
- Initiation Date
- August 29, 2017
- Termination Date
- August 21, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 93,600 tablets
Product Description
Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only. Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-390-01
Reason for Recall
Failed Stability Specifications
Distribution Pattern
Nationwide USA and Puerto Rico
Code Information
Lot #:167194; Exp. 12/31/2018