Drug recall
Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and 4"x8"(NDC…
FDA recall event 75982 · Class II · Gentell, Inc
Key facts
| Event ID | 75982 |
|---|---|
| Recall numbers | D-0242-2017, D-0243-2017 |
| Recalling firm | Gentell, Inc |
| Product type | Drugs |
| Products | Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and 4"x8"(NDC 61554-118-28), Manufactured by: Gentell, 2701 Bartram Road, Bristol, PA 19007, Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell, 2701 Bristol, PA 19007, NDC 61554-111-04 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | CGMP Deviations |
| Initiation date | Dec 15, 2016 |
| Report date | Jan 11, 2017 |
| Termination date | Feb 16, 2018 |
| City | Bristol |
| State | PA |
| Country | United States |
| FEI number | 1000522686 |
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: