FDAFDA · Food and drugs·Recall number D-0303-2021
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
Published March 24, 2021 · Recall initiated: January 27, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
- Distributor
- Nationwide in the USA
- Lot
- a) Lot #: 148969, Exp 7/31/2022, b) Lot #: 148791, Exp 7/31/2022, c) Lot #: 148991, Exp 7/31/2022
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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