Home / Recalls / Edge Pharma, LLC / D-0404-2022

D-0404-2022 Class II Terminated

Recalled by Edge Pharma, LLC — Colchester, VT

FDA drug recall D-0404-2022 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: 1202 syringes.

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: 1202 syringes

Product Description

Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile Ophthalmic Solution for Injection (PF), 2%/0.375%, 8 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1548-18

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

nationwide

Code Information

10-2021-26@3 12/04/2021 11-2021-09@1 12/23/2021

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-0422-2022 Class II — Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic S (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-0415-2022 Class II — Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe (December 6, 2021)