D-0304-2021 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- March 24, 2021
- Initiation Date
- January 27, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 bottles
Product Description
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
Reason for Recall
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: 148992, Exp 5/31/2022