Phenylephrine HCl/Tropicamide/Cyclopentolate recall: Sterility Concern
Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.5%/0.25%/0.25%/0.125%, 0.5 mL syringe, Single Use Syringe…
Why was Phenylephrine HCl/Tropicamide/Cyclopentolate recalled?
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?
09-2021-15@2 12/28/2021 & 11-2021-02@3 02/14/2022
- Product
- Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.5%/0.25%/0.25%/0.125%, 0.5 mL syringe, Single Use Syringe…
- Recalling firm
- Edge Pharma, LLC
- Quantity
- 2562 syringes
- Distribution
- nationwide
- Recall date
- February 2, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)