Recalls / Class II
Class IID-0335-2021
Product
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
- Affected lot / code info
- Lot 02-2021-16@4 BUD 5/31/2021
Why it was recalled
Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
Recalling firm
- Firm
- Edge Pharma, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 856 Hercules Dr, N/A, Colchester, Vermont 05446-8014
Distribution
- Quantity
- 5850 syringes
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2021-04-12
- FDA classified
- 2021-04-19
- Posted by FDA
- 2021-04-28
- Terminated
- 2022-02-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0335-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.