Glenmark Pharmaceuticals Inc., USA recalls Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot N…

Recall date

March 25, 2019

Source

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

Recall number

D-1120-2019

FDA classification

Class II

Brand / firm

Glenmark Pharmaceuticals Inc., USA

Sold / distributed

Nationwide in the USA

Why it was recalled

Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.

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

What was recalled

Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma zone SEZ, Pithampur, Dist-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. NDC 68462-196-05