Records and reported status
Dec 6, 2021 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: nationwide
Official source for Phenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic Solution, 10%/1%/0.... Dec 6, 2021 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: nationwide
Official source for Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV Injection,... Dec 6, 2021 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: nationwide
Official source for Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe for IV Injection, E... Dec 6, 2021 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: nationwide
Official source for Phenylephrine HCl, Sterile Solution for Injection, (PF), 800 mcg/10mL (80 mcg/mL), Single Use Syr... Dec 6, 2021 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: nationwide
Official source for PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL), Single use bag for... Dec 6, 2021 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: nationwide
Official source for Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preservative Free, 1.5%/1... Dec 6, 2021 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: nationwide
Official source for Phenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL per dropper, Multiple ... Dec 6, 2021 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: nationwide
Official source for Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.5%/0.25... Dec 6, 2021 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: nationwide
Official source for Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution, 10%/ 0.2... Dec 6, 2021 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: nationwide
Official source for Betadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5% 0.5mL per syringe,... Dec 6, 2021 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: nationwide
Official source for Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free, 8 mg/0.8mL (10 mg/m... Dec 6, 2021 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: nationwide
Official source for Vancomycin HCl in 0.9 % Sodium Chloride Injection, USP, 1,250 mg/250 mL, Single Use Bag for IV In... Dec 6, 2021 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: nationwide
Official source for Vancomycin HCl in 0.9% Sodium Chloride Injection, 1,500 mg/500 mL, USP, Single Use Bag for IV Inj... Dec 6, 2021 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: nationwide
Official source for Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single Use Bag for IV Injec... Dec 6, 2021 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: nationwide
Official source for BLT Topical Cream, Benzocaine/Lidocaine/Tetracaine, 20%/8%/4%, 60gm per jar, Multiple Dose Contai... Dec 6, 2021 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: nationwide
Official source for Cantharidin Gel-Forming Suspension, 0.7%, 10 mL per vial, Multiple Dose Vial for Topical Use, Edg... Dec 6, 2021 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: nationwide
Official source for Cantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming Suspension, 10 mL per vial, Multiple Dos... Dec 6, 2021 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: nationwide
Official source for CSF Otic Insufflation Capsule, Sulfacetamide Sodium/ Ciprofloxacin/ Amphotericin B Otic Powder, 5... Dec 6, 2021 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: nationwide
Official source for CSF-HC Otic Insufflation Capsule, Sulfacetamide Sodium/Ciprofloxacin/Hydrocortisone/Amphotericin ... Dec 6, 2021 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: nationwide
Official source for Dexamethasone sodium phosphate 0.4%, 120 mL per bottle, Multiple Dose Container For Topical Use, ... Reasons in these listed records Lack of Assurance of Sterility CGMP Deviations 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.