D-0304-2021 Class II Ongoing

Recalled by Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals — Burbank, CA

Recall Details

Product Type
Drugs
Report Date
March 24, 2021
Initiation Date
January 27, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12 bottles

Product Description

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

Reason for Recall

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

Distribution Pattern

Nationwide in the USA

Code Information

Lot #: 148992, Exp 5/31/2022