Edge Pharma, LLC: Drug Recall
Recall #D-0335-2021 · 04/12/2021
Class II: Risk
Recall Details
- Recall Number
- D-0335-2021
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Edge Pharma, LLC
- Status
- Terminated
- Date Initiated
- 04/12/2021
- Location
- Colchester, VT, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5850 syringes
Reason for Recall
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
Distribution Pattern
Nationwide in the US
Other Recalls by Edge Pharma, LLC
- Class II: Risk 12/06/2021
- Class II: Risk 12/06/2021
- Class II: Risk 12/06/2021
- Class II: Risk 12/06/2021
- Class II: Risk 12/06/2021
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.