Drug recall
Hydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Manufactured for: Westminster…
FDA recall event 88755 · Class II · Monarch PCM, LLC
Key facts
| Event ID | 88755 |
|---|---|
| Recall numbers | D-0855-2021 |
| Recalling firm | Monarch PCM, LLC |
| Product type | Drugs |
| Products | Hydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN 37217 NDC 69367-174-01 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Finished product specification did not meet USP specifications. |
| Initiation date | Sep 23, 2021 |
| Report date | Oct 6, 2021 |
| Termination date | Jun 23, 2023 |
| City | Fort Worth |
| State | TX |
| Country | United States |
| FEI number | 3012816585 |
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: