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
Reported: March 24, 2021 Initiated: January 27, 2021 #D-0304-2021
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.
Details
- Recalling Firm
- Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
- Units Affected
- 12 bottles
- Distribution
- Nationwide in the USA
- Location
- Burbank, CA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals. Units affected: 12 bottles.
Why was this product recalled? ▼
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 24, 2021. Severity: Moderate. Recall number: D-0304-2021.
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