FDAFDA · Food and drugs·Recall number D-0421-2022
Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.5%/0.25%/0.25%/0.125%, 0.5 mL syringe, Single Use Syringe, For Topical Ophthalmic Use, NDC 05446-0993-01
Published February 2, 2022 · Recall initiated: December 6, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Edge Pharma, LLC
- Distributor
- nationwide
- Lot
- 09-2021-15@2 12/28/2021 & 11-2021-02@3 02/14/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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