D-0992-2018 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 1, 2018
- Initiation Date
- June 27, 2018
- Termination Date
- December 4, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25, 30-count bottles
Product Description
Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-30
Reason for Recall
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Distribution Pattern
Distributed Nationwide in the USA
Code Information
Lots: 51904-2, EXP: 01/31/2018; 51904-3, EXP: 02/28/2018; 51904-5, EXP: 03/31/2018; 52885-2, EXP: 03/31/2018, 53840-1, EXP: 5/28/2018.