Gentell Hydrogel Wound Dressing REGULAR — Class II drug recall D-0243-2017
Terminated recall by Gentell, Inc, reported 2017-01-11. CGMP Deviations
| Recall number | D-0243-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gentell, Inc, Bristol, PA, United States |
| Recall initiated | 2016-12-15 |
| Classified | 2017-01-02 |
| Reported by FDA | 2017-01-11 |
| Terminated | 2018-02-16 |
| Reason classes | cgmp |
| NDC | 61554-0111-04 |
| Lot numbers | 11/18, 1100616, 1102616, 1105516, 1106216, 1106816, 1108816, 1109616, 1110316, 1111816, 1114116, 1116616, 1118716, 1119516, 1121516, 1121615, 1121713, 1122215, 1123116, 1123315, 1125215, 1126515, 1127315, 1130015, 1131615, 1133615, 1136215, 1136415 |
Product
Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell, 2701 Bristol, PA 19007, NDC 61554-111-04
Reason for recall
CGMP Deviations
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0243-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.