Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals recalls Spironolactone Tablets, USP, 50 mg, packaged in 30-count bottles, Rx only, Manufactured by: Frontida BioPharm, Inc., Ph…

Recall date

January 27, 2021

Source

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

Recall number

D-0304-2021

FDA classification

Class II

Brand / firm

Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals

Sold / distributed

Nationwide in the USA

Why it was recalled

Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.

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

What was recalled

Spironolactone Tablets, USP, 50 mg, packaged in 30-count bottles, Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124 USA, Repackaged by: Bryant Ranch Prepack, Inc., Burbank, CA 91504 USA, NDC 63629-1067-01