Class I
Ongoing
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
This recall is currently active, issued March 24, 2021. It was issued by Bryant Ranch Prepack, Inc. Dba Brp Pharmaceuticals.
- Recall Initiated
- January 27, 2021
- Posted
- March 24, 2021
- Recall Number
- D-0303-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 35 bottles
- Firm Location
- Burbank, CA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets.
Distribution
Nationwide in the USA
Lot / Code Info
a) Lot #: 148969, Exp 7/31/2022, b) Lot #: 148791, Exp 7/31/2022, c) Lot #: 148991, Exp 7/31/2022
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