Drug recall
Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15); b) 30 g tubes (NDC…
FDA recall event 78974 · Class III · G & W Laboratories, Inc.
Key facts
| Event ID | 78974 |
|---|---|
| Recall numbers | D-0250-2018 |
| Recalling firm | G & W Laboratories, Inc. |
| Product type | Drugs |
| Products | Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15); b) 30 g tubes (NDC 0713-0638-31); and c) 90 g tubes (NDC 0713-0638-18), Rx Only, Manufactured by: G&W Laboratories… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration. |
| Initiation date | Jan 19, 2018 |
| Report date | Feb 14, 2018 |
| Termination date | Feb 3, 2020 |
| City | South Plainfield |
| State | NJ |
| Country | United States |
| FEI number | 2210277 |
At a glance
- 1–9 Products in this recall
- 10–99 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: