Betadine recall: Sterility Concern
Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT) STERILE OPHTHALMIC SOLUTION…
Why was Betadine recalled?
Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 02-2021-16@4 BUD 5/31/2021
- Product
- Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT) STERILE OPHTHALMIC SOLUTION…
- Recalling firm
- Edge Pharma, LLC
- Quantity
- 5850 syringes
- Distribution
- Nationwide in the US
- Recall date
- April 28, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)