FDA Recall D-0303-2021

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

Class I — life-threatening Ongoing 1933 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

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

Lot / code: a) Lot #: 148969, Exp 7/31/2022, b) Lot #: 148791, Exp 7/31/2022, c) Lot #: 148991, Exp 7/31/2022

Quantity: 35 bottles

Reason for recall

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

Recall record

Recall number: D-0303-2021
Classification: Class I
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

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

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

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