Wockhardt Usa Inc. recalls Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured by: Wockhardt Limited H-14/2, M.I.D.C. A…

Recall date

August 22, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0051-2018

FDA classification

Class III

Brand / firm

Wockhardt Usa Inc.

Sold / distributed

Nationwide in the USA

Why it was recalled

Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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;