Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals: Drug Recall

Recall #D-0303-2021 · 01/27/2021

Class I: Dangerous

Recall Details

Recall Number: D-0303-2021
Classification: Class I
Product Type: Drug
Recalling Firm: Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Status: Ongoing
Date Initiated: 01/27/2021
Location: Burbank, CA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 35 bottles

Reason for Recall

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

Product Description

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

Distribution Pattern

Nationwide in the USA

Other Recalls by Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals

Class I: Dangerous 10/12/2021

Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets
Class III: Low Risk 09/28/2021

Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
Class III: Low Risk 09/28/2021

Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
Class II: Risk 01/27/2021

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

View all recalls by Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.