Drug recall
Spironolactone Tablets, USP, 25 mg, packaged in: a) 30-count bottles (NDC 63629-1064-01), b) 60-count bottles…
FDA recall event 87283 · Class I, Class II · Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Key facts
| Event ID | 87283 |
|---|---|
| Recall numbers | D-0303-2021, D-0304-2021 |
| Recalling firm | Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals |
| Product type | Drugs |
| Products | 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…, 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… |
| Classification | Class I, Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets., Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets. |
| Initiation date | Jan 27, 2021 |
| Report date | Mar 24, 2021 |
| City | Burbank |
| State | CA |
| Country | United States |
| FEI number | 1000519407 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: