FDA recall D-0303-2021

Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals · Class I · drug

Product

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

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status: Ongoing
Initiation date: 2021-01-27
Report date: 2021-03-24
Voluntary/Mandated: Voluntary: Firm initiated
Location: Burbank, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0303-2021