Edge Pharma, LLC
Edge Pharma, LLC appears in FDA public data with 62 recalls, 0 510(k) clearances, 4 FDA inspections, and 2 compliance actions on record. Its most recent recall (D-0420-2022, Class II) was initiated on December 6, 2021.
Summary
- Total Recalls
- 62
- 510(k) Clearances
- 0
- Inspections
- 4
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0420-2022 | Class II | Phenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL per dropper, Multiple Dos | December 6, 2021 |
| D-0444-2022 | Class II | Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Multiple Dose Container, E | December 6, 2021 |
| D-0434-2022 | Class II | Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL per vial, Edge Pharma, LL | December 6, 2021 |
| D-0436-2022 | Class II | LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose Container for Topical Us | December 6, 2021 |
| D-0398-2022 | Class II | Cefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg/0.3mL (10 mg/mL), 0.3 | December 6, 2021 |
| D-0448-2022 | Class II | Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syringe, Single Dose Syringe | December 6, 2021 |
| D-0422-2022 | Class II | Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution, 10%/ 0.25%/ | December 6, 2021 |
| D-0427-2022 | Class II | Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single Use Bag for IV Injectio | December 6, 2021 |
| D-0416-2022 | Class II | Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe for IV Injection, Edge | December 6, 2021 |
| D-0440-2022 | Class II | Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% / 4%, Spearmint-Peppermi | December 6, 2021 |
| D-0449-2022 | Class II | Trypan Blue 0.03%, 0.5mL per syringe, Sterile Ophthalmic Solution for Injection Preservative Free, S | December 6, 2021 |
| D-0410-2022 | Class II | Moxifloxacin, Sterile Ophthalmic Solution for Injection, Preservative Free, 0.8mg/0.8 mL (1mg/mL), 0 | December 6, 2021 |
| D-0445-2022 | Class II | Vitamin K (Vitamin K ) Oral Solution (PF), 5 mg/mL, 1mL per syringe, single Dose Syringe for Oral Us | December 6, 2021 |
| D-0437-2022 | Class II | LET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine HCl, 4%/0.05%/0.5%, 3 mL per syringe, Sin | December 6, 2021 |
| D-0396-2022 | Class II | Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / 1:100,000, 3 mL per syr | December 6, 2021 |
| D-0402-2022 | Class II | Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservative Free, 0.025%/0.75% | December 6, 2021 |
| D-0404-2022 | Class II | Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile Ophthalmic Solution fo | December 6, 2021 |
| D-0428-2022 | Class II | BLT Topical Cream, Benzocaine/Lidocaine/Tetracaine, 20%/8%/4%, 60gm per jar, Multiple Dose Container | December 6, 2021 |
| D-0408-2022 | Class II | Mitomycin-C Sterile Ophthalmic Solution, Preservative Free, 0.32mg/0.8 mL (0.4mg/mL) 0.8 mL per syri | 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 for IV Injection, Ed | December 6, 2021 |