FDA recall D-0051-2018

Product

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

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2017-08-22

Report date

2017-11-01

Termination date

2019-02-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0051-2018