Macleods Pharma Usa Inc recalls Telmisartan and Hyrdochlorothiazide Tablets 80 mg/25 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma U…

Recall date

February 25, 2019

Source

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

Recall number

D-1005-2019

FDA classification

Class II

Brand / firm

Macleods Pharma Usa Inc

Sold / distributed

Nationwide within the United States

Why it was recalled

Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Telmisartan and Hyrdochlorothiazide Tablets 80 mg/25 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-130-07