Gentell Hydrogel Wound Dressing Recalled for CGMP Deviations
Gentell, Inc. is voluntarily recalling Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tubes due to Current Good Manufacturing Practice (CGMP) deviations.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to CGMP deviations, which falls under the 'Moderate' category for voluntary precautionary recalls without reported illnesses or injuries.
Plain-English summary
Gentell, Inc. is voluntarily recalling Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tubes (NDC 61554-111-04) in the United States. The recall was initiated on December 15, 2016, and was classified as Class II by the FDA. The reason for the recall is cited as Current Good Manufacturing Practice (CGMP) deviations.
The affected product includes 4 oz. tubes with Gen Code 11240 and specific lot numbers ranging from 1121615 to 1123116, with an expiration date of 11/18. The recall status is currently terminated as of February 16, 2018. The firm notified customers via email.
Consumers who have this product should stop using it and contact Gentell, Inc. for further instructions or a refund, as per standard recall procedures for CGMP deviations.
The recalled product
- Product
- Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell, 2701 Bristol, PA 19007, NDC 61554-111-04
- Manufacturer
- Gentell, Inc
- Category
- Drug — Wound Dressing
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Gentell, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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