Drug product
Spironolactone Tablets, USP, 50 mg, packaged in 30-count bottles, Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124 USA, Repackaged by: Bryant Ranch Prepack, Inc., Burbank, CA 91504 USA, NDC 63629-1067-01
D-0304-2021
Product summary
- Event
- Event 87283
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 12 bottles
- Official record key
drug-enforcement:D-0304-2021
Official wording
Reason: Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.
Code information: Lot #: 148992, Exp 5/31/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-Up