D-0335-2021 Class II Terminated
FDA drug recall D-0335-2021 was initiated by Edge Pharma, LLC on April 12, 2021 and is designated Class II. Reason for recall: Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility The recall status is terminated (terminated February 11, 2022). Affected quantity: 5850 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- April 28, 2021
- Initiation Date
- April 12, 2021
- Termination Date
- February 11, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5850 syringes
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
Reason for Recall
Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
Distribution Pattern
Nationwide in the US
Code Information
Lot 02-2021-16@4 BUD 5/31/2021