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D-0422-2022 Class II Terminated

Recalled by Edge Pharma, LLC — Colchester, VT

FDA drug recall D-0422-2022 was initiated by Edge Pharma, LLC on December 6, 2021 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated June 7, 2023). Affected quantity: 40 droptainers.

Recall Details

Product Type: Drugs
Report Date: February 2, 2022
Initiation Date: December 6, 2021
Termination Date: June 7, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 40 droptainers

Product Description

Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution, 10%/ 0.25%/ 0.25%/0.125%, 10 mL per dropper, Multiple Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, NDC 05446-0859-03

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

nationwide

Code Information

11-2021-02@2 12/16/2021

Other recalls by Edge Pharma, LLC

D-0420-2022 Class II — Phenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL per d (December 6, 2021)
D-0444-2022 Class II — Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Multip (December 6, 2021)
D-0434-2022 Class II — Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL per v (December 6, 2021)
D-0436-2022 Class II — LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose Cont (December 6, 2021)
D-0398-2022 Class II — Cefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg/0. (December 6, 2021)
D-0448-2022 Class II — Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syringe, (December 6, 2021)
D-0427-2022 Class II — Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single Use (December 6, 2021)
D-0416-2022 Class II — Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe fo (December 6, 2021)
D-0440-2022 Class II — Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% / 4% (December 6, 2021)
D-0415-2022 Class II — Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe (December 6, 2021)