FDAFDA · Food and drugs·Recall number D-0243-2017
Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell, 2701 Bristol, PA 19007, NDC 61554-111-04
Published January 11, 2017 · Recall initiated: December 15, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Gentell, Inc
- Distributor
- United States
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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