Drug product
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
D-0242-2017
Product summary
- Firm
- Gentell, Inc
- Event
- Event 75982
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,000 gauzes
- Official record key
drug-enforcement:D-0242-2017
Official wording
Reason: CGMP Deviations
Code information: Gentell Hydrogel AG 2X2 (Gen-11260) Lot #: 1121615, 1121713, 1122215; Exp. 11/18 Gentell Hydrogel AG 4X4 (Gen-11460) Lot #: 1123315, 1125215, 1126515; Exp. 11/18 Gentell Hydrogel AG 4X8 (Gen-11860) Lot #: 1127315, 1130015, 1133615; Exp. 11/18
Distribution pattern: United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations