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
Reported: March 24, 2021 Initiated: January 27, 2021 #D-0303-2021
Product Description
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
Reason for Recall
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets.
Details
- Recalling Firm
- Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
- Units Affected
- 35 bottles
- Distribution
- Nationwide in the USA
- Location
- Burbank, CA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals. Units affected: 35 bottles.
Why was this product recalled? ▼
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 24, 2021. Severity: Critical. Recall number: D-0303-2021.
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