Recalls / Class I
Class ID-0303-2021
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Affected lot / code info
- a) Lot #: 148969, Exp 7/31/2022, b) Lot #: 148791, Exp 7/31/2022, c) Lot #: 148991, Exp 7/31/2022
Why it was recalled
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets.
Recalling firm
- Firm
- Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 1919 N Victory Pl, N/A, Burbank, California 91504-3425
Distribution
- Quantity
- 35 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2021-01-27
- FDA classified
- 2021-03-16
- Posted by FDA
- 2021-03-24
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0303-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.