Class II
Terminated
Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell, 2701 Bristol, PA 19007, NDC 61554-111-04
- Company
- Gentell, Inc
- Recall Initiated
- December 15, 2016
- Posted
- January 11, 2017
- Recall Number
- D-0243-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- unknown
- Firm Location
- Bristol, PA, United States
Reason for Recall
CGMP Deviations
Distribution
United States
Lot / Code Info
4 oz. tube: Gen Code 11240 Lot #: 1121615, 1121713, 1122215, 1123315, 1125215, 1126515, 1127315, 1130015, 1133615, 1131615, 1136215, 1136415, 1100616, 1102616, 1105516, 1106216, 1106816, 1108816, 1109616, 1110316, 1111816, 1114116, 1116616, 1118716, 1119516, 1121516, 1123116; Exp. 11/18
More recalls by Gentell, Inc
Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing containing hydrogel and hon...
Mar 26, 2020
Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing containing hydrogel and hon...
Mar 26, 2020
Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing hydrogel and honey (100% Lepto...
Mar 26, 2020
Other recent Class II Drug recalls
Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, L...
Wizcure Pharmaa Private Limited
· Mar 4, 2026
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: Av...
Avkare
· Mar 4, 2026
Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX I...
Agebox
· Mar 4, 2026
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPL...
Leo Pharma Inc
· Mar 4, 2026
Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per...
Pro Numb Tattoo Numbing Spray Llc
· Feb 18, 2026