Drug 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
D-0335-2021
Product summary
- Firm
- Edge Pharma, LLC
- Event
- Event 87710
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5850 syringes
- Official record key
drug-enforcement:D-0335-2021
Official wording
Reason: Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
Code information: Lot 02-2021-16@4 BUD 5/31/2021
Distribution pattern: Nationwide in the US
Derived failure modes
-
Sterility assurance
lack of assurance of sterility