Glenmark Pharmaceuticals Inc., USA recalls Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Ba…

Recall date

March 19, 2018

Source

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

Recall number

D-0606-2018

FDA classification

Class III

Brand / firm

Glenmark Pharmaceuticals Inc., USA

Sold / distributed

Nationwide in the United States.

Why it was recalled

Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One or two capsules 2 or 3 times a day." rather than the correct usual adult dosage of "One capsule 2 or 3 times a day.

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

What was recalled

Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-302-01.