FDA-Drug2021-03-24Class II

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

Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Hazard

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

Sold states
Nationwide in the USA
Affected count
12 bottles
Manufactured in
1919 N Victory Pl, N/A, Burbank, CA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0304-2021

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