FDA Recall D-0304-2021

Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals · Burbank, CA

Class II Ongoing 1933 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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

Lot / code: Lot #: 148992, Exp 5/31/2022

Quantity: 12 bottles

Reason for recall

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

Recall record

Recall number: D-0304-2021
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Nationwide in the USA
Recall initiated: 2021-01-27
Classified by FDA Center: 2021-03-16
FDA published: 2021-03-24
Recalling firm: Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Firm location: Burbank, CA

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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