Drug recall
Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc…
FDA recall event 91532 · Class III · Lupin Pharmaceuticals Inc.
Key facts
| Event ID | 91532 |
|---|---|
| Recall numbers | D-0174-2023 |
| Recalling firm | Lupin Pharmaceuticals Inc. |
| Product type | Drugs |
| Products | Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Subpotent Drug: Low assay result observed during long-term stability testing. |
| Initiation date | Jan 20, 2023 |
| Report date | Feb 1, 2023 |
| Termination date | Jan 16, 2024 |
| City | Baltimore |
| State | MD |
| Country | United States |
| FEI number | 3004097115 |
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: