Why it was recalled
Microbial Contamination of Non-Sterile Products and Superpotent Drug: FDA analysis revealed microbial contamination in addition to high out of specification results for iron content.
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 #: 579634, 579635, Exp 5/2020
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-1528-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 19, 2019
- FDA report date
- Jul 31, 2019
- Quantity
- 277 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dercher Enterprises, Inc., DBA Gordon Laboratories
Original FDA data
Every field from FDA enforcement report D-1528-2019, exactly as published.
Show all FDA fields
- City
- Upper Darby
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 83399
- Address
- 6801 Ludlow St
- Code information
- Batch #: 579634, 579635, Exp 5/2020
- Postal code
- 19082-2408
- Report date
- Jul 31, 2019
- Product type
- Drugs
- Recall number
- D-1528-2019
- Classification
- Class II
- Recalling firm
- Dercher Enterprises, Inc., DBA Gordon Laboratories
- Product quantity
- 277 boxes
- Termination date
- Aug 14, 2023
- Reason for recall
- Microbial Contamination of Non-Sterile Products and Superpotent Drug: FDA analysis revealed microbial contamination in addition to high out of specification results for iron content.
- 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
- Jul 19, 2019
- Initial firm notification
- Letter
- Center classification date
- Jul 25, 2019