Records and reported status
Dec 6, 2021 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: nationwide
Official source for ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300 ml, IV ... Dec 6, 2021 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: nationwide
Official source for Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syringe, Single Use Syrin... Dec 6, 2021 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: nationwide
Official source for Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / 1:100,000, 3 mL per ... Dec 6, 2021 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: nationwide
Official source for Ceftazidime, Sterile Ophthalmic Solution for Injection, Preservative Free (11.25 mg/0.5 mL (22.5 ... Dec 6, 2021 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: nationwide
Official source for Cefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg/0.3mL (10 mg/mL), 0... Dec 6, 2021 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: nationwide
Official source for Dexamethasone sodium phosphate, sterile otic solution for injection Preservative free, 19.2 mg/0.... Dec 6, 2021 FDA drug enforcement
Lack of Assurance of Sterility.
Class II Reported terminated
Distribution: nationwide
Official source for Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper, Single Dose Dr... Dec 6, 2021 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: nationwide
Official source for Edetate Disodium (EDTA), Sterile Ophthalmic Solution, (PF) 3%, 10mL per dropper, Single Dose Drop... Dec 6, 2021 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: nationwide
Official source for Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservative Free, 0.025%/0.... Dec 6, 2021 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: nationwide
Official source for Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL), 50 mL per syri... Dec 6, 2021 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: nationwide
Official source for Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile Ophthalmic Solution... Dec 6, 2021 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: nationwide
Official source for Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preservative Free, 3 mL p... Dec 6, 2021 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: nationwide
Official source for Methotrexate, USP, Sterile Solution for Injection (PF), 125 mg/5mL (2mg/mL), 5 mL per syringe, Ed... Dec 6, 2021 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: nationwide
Official source for Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL per syringe, Single Dose Syringe for Intravesical Use, Edg... Dec 6, 2021 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: nationwide
Official source for Mitomycin-C Sterile Ophthalmic Solution, Preservative Free, 0.32mg/0.8 mL (0.4mg/mL) 0.8 mL per s... Dec 6, 2021 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: nationwide
Official source for Mitomycin-C, Sterile Ophthalmic Solution, Preservative Free, 0.16mg/0.8mL (0.2 mg/mL), 0.8 mL per... Dec 6, 2021 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: nationwide
Official source for Moxifloxacin, Sterile Ophthalmic Solution for Injection, Preservative Free, 0.8mg/0.8 mL (1mg/mL)... Dec 6, 2021 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: nationwide
Official source for Neostigmine methylsulfate, 5 mg/5mL (1 mg/mL), 5 mL per syringe, Single Use Syringe for IV or IM ... Dec 6, 2021 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: nationwide
Official source for MVASI, (bevacizumab-awwb), Sterile Ophthalmic Solution for Injection, 3.25mg/0.13mL (25 mg/mL) 0.... Dec 6, 2021 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: nationwide
Official source for Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vial for Perineural In...
Reasons in these listed records Lack of Assurance of Sterility Lack of Assurance of Sterility. These examples come from this result page and are not a ranking of every recall reason.
Checking Edge Pharma, LLC Is there a recall on edge pharma, llc right now? This archive contains 56 records, including 0 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Where can I find older records? Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.