D-0051-2018 Class III Terminated
FDA drug recall D-0051-2018 was initiated by Wockhardt Usa Inc. on Aug 22, 2017 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound. The recall status is terminated (terminated Feb 27, 2019). Affected quantity: 5050 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Nov 1, 2017
- Initiation Date
- Aug 22, 2017
- Termination Date
- Feb 27, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5050 bottles
Product description
Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured by: Wockhardt Limited H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India, Distributed by: Wockhardt, USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054, USA. NDC: 64679-924-03;
Reason for recall
Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
Distribution pattern
Nationwide in the USA
Code information
Lot # DR10635, EXP 05/2019; DR10636, EXP 05/2019.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0051-2018
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026