Monsel's (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories, Upper Darby, PA 19082, NDC 10481-0112-8.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Batch #: 579602, 579604, 579606, Exp 12/18; 579609, Exp 04/19.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Gordon Laboratories
- Reason for Recall:
- Superpotent Drug: contains higher levels of Iron than labeled.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Monsel's (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories, Upper Darby, PA 19082, NDC 10481-0112-8.
Product Codes/Lot Numbers:
Batch #: 579602, 579604, 579606, Exp 12/18; 579609, Exp 04/19.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0338-2019