FDAJanuary 27, 2021drug

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

bryant ranch prepack inc dba brp pharmaceuticalsbryantbryant ranch

UPCs

63629106701

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 — Recall Details · AllClear