Why it was recalled
Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
Product description
Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT) STERILE OPHTHALMIC SOLUTION, PRESERVATIVE FREE, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178
Lot numbers, UPCs & expiration codes
Lot 02-2021-16@4 BUD 5/31/2021
Where it was sold
Nationwide in the US
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-0335-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 12, 2021
- FDA report date
- Apr 28, 2021
- Quantity
- 5850 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Edge Pharma, LLC
Original FDA data
Every field from FDA enforcement report D-0335-2021, exactly as published.
Show all FDA fields
- City
- Colchester
- State
- VT
- Status
- Terminated
- Country
- United States
- Event ID
- 87710
- Address
- 856 Hercules Dr
- Code information
- Lot 02-2021-16@4 BUD 5/31/2021
- Postal code
- 05446-8014
- Report date
- Apr 28, 2021
- Product type
- Drugs
- Recall number
- D-0335-2021
- Classification
- Class II
- Recalling firm
- Edge Pharma, LLC
- Product quantity
- 5850 syringes
- Termination date
- Feb 11, 2022
- Reason for recall
- Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT) STERILE OPHTHALMIC SOLUTION, PRESERVATIVE FREE, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Apr 12, 2021
- Initial firm notification
- Letter
- Center classification date
- Apr 19, 2021