Why it was recalled
Superpotent Drug: contains higher levels of Iron than labeled.
Product 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.
Lot numbers, UPCs & expiration codes
Batch #: 579602, 579604, 579606, Exp 12/18; 579609, Exp 04/19.
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0338-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 10, 2018
- FDA report date
- Dec 26, 2018
- Quantity
- 1,155 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Gordon Laboratories
Original FDA data
Every field from FDA enforcement report D-0338-2019, exactly as published.
Show all FDA fields
- City
- Upper Darby
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 81719
- Address
- 6801 Ludlow St
- Code information
- Batch #: 579602, 579604, 579606, Exp 12/18; 579609, Exp 04/19.
- Postal code
- 19082-2408
- Report date
- Dec 26, 2018
- Product type
- Drugs
- Recall number
- D-0338-2019
- Classification
- Class II
- Recalling firm
- Gordon Laboratories
- Product quantity
- 1,155 boxes
- Termination date
- Dec 2, 2020
- Reason for recall
- Superpotent Drug: contains higher levels of Iron than labeled.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Dec 10, 2018
- Initial firm notification
- Letter
- Center classification date
- Dec 17, 2018