Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals recalls Spironolactone Tablets, USP, 25 mg, packaged in: a) 30-count bottles (NDC 63629-1064-01), b) 60-count bottles (NDC 6362…

Recall date

January 27, 2021

Source

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

Recall number

D-0303-2021

FDA classification

Class I

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 25 mg may contain spironolactone 50 mg tablets.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Spironolactone Tablets, USP, 25 mg, packaged in: a) 30-count bottles (NDC 63629-1064-01), b) 60-count bottles (NDC 63629-1064-02), c) 90-count bottles (NDC 63629-1064-03), Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124 USA, Repackaged by: Bryant Ranch Prepack, Inc., Burbank, CA 91504 USA