Amerigel Wound Dressing recall: CGMP Deviations
Amerigel Wound Dressing 1 oz. tube
Why was Amerigel Wound Dressing recalled?
Product may not have been manufactured pursuant to a validated process protocol and CGMP.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #3WD02, Lot #3WD03, Lot #3WD04 and Lot #3WD05.
- Product
- Amerigel Wound Dressing 1 oz. tube
- Recalling firm
- Kova Laboratories, Inc.
- Quantity
- 122,396 / 1oz. tubes
- Distribution
- Distributed in the states of FL and NJ.
- Recall date
- July 16, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)