D-0991-2018 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
- 61, 90-count bottles
Product Description
Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-90
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: 51904-1, EXP: 01/31/2018; 51904-4, 52885-1, EXP: 03/31/2018; 52885-3, EXP: 04/30/2018; 52885-4,EXP: 05/28/2018; 53840-2,EXP: 5/28/2018; 53840-3, EXP:6/30/2018; 53840-4, EXP:8/31/2018; 56665-1, EXP: 01/31/2019; 58596-1, EXP: 05/28/2019.