Macleods Pharma Usa Inc recalls Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods…

Recall date

January 24, 2020

Source

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

Recall number

D-0838-2020

FDA classification

Class III

Brand / firm

Macleods Pharma Usa Inc

Sold / distributed

Nationwide

Why it was recalled

Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.

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

What was recalled

Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, India, NDA 33342-176-09