Drug 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
D-0303-2021
Product summary
- Event
- Event 87283
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 35 bottles
- Official record key
drug-enforcement:D-0303-2021
Official wording
Reason: Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets.
Code information: a) Lot #: 148969, Exp 7/31/2022, b) Lot #: 148791, Exp 7/31/2022, c) Lot #: 148991, Exp 7/31/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-Up