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  3. Recall Enforcement Event ID: 91788

Recall Enforment Report D-0820-2023

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Akorn, Inc., originally initiated on 04-26-2023 for the product Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs The product was recalled due to cgmp deviations: firm went out of business and could no longer continue stability studies.. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0820-202304-26-202306-07-2023Class IIN/ALevofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0821-202304-26-202306-07-2023Class IIN/ALidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes, Rx Only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0803-202304-26-202306-07-2023Class IIN/AFerrous Sulfate Iron Supplement Drops, packaged in 50 mL bottles, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0854-202304-26-202306-07-2023Class IIN/AValproic Acid Oral Solution, USP, 250mg/5mL, 473 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0809-202304-26-202306-07-2023Class IIN/AHydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials, For Intramuscular or Intravenous Use, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0833-202304-26-202306-07-2023Class IIN/AOlopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0840-202304-26-202306-07-2023Class IIN/ARifampin Capsules USP, 150 mg, 30-count bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0817-202304-26-202306-07-2023Class IIN/ALevocarnitine Oral Solution, USP, 118 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0796-202304-26-202306-07-2023Class IIN/AClobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0858-202304-26-202306-07-2023Class IIN/ACalcitriol Injection 2 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0835-202304-26-202306-07-2023Class IIN/APilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0862-202304-26-202306-07-2023Class IIN/APilocarpine Hydrochloride Ophthalmic Solution, USP 4%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0806-202304-26-202306-07-2023Class IIN/AGranisetron HCl Injection, USP, 1 mg/mL, packaged in a) 1mL and b) 4 mL vials, Rx Only, For Intravenous Use Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0839-202304-26-202306-07-2023Class IIN/AProparacaine HCl Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0828-202304-26-202306-07-2023Class IIN/AMidazolam Injection, USP 2mg/2mL (1 mg/mL) For Intramuscular or Intravenous Use Only, 2mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0789-202304-26-202306-07-2023Class IIN/ACalcipotriene Topical Solution, 0.005% (Scalp Solution), 60 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0813-202304-26-202306-07-2023Class IIN/AKetorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile, packaged in a) 3mL bottles, b bottles) 5 mL, and c)10 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0781-202304-26-202306-07-2023Class IIN/AAcetic Acid Otic Solution, 15 mL per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0859-202304-26-202306-07-2023Class IIN/AMidazolam Injection, USP, 50 mg/10mL (5mg/mL), For Intramuscular or Intravenous Use Only, 10 mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0864-202304-26-202306-07-2023Class IIN/ATropicamide Ophthalmic Solution, USP 0.1%, 15 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0851-202304-26-202306-07-2023Class IIN/ATobramycin Ophthalmic Solution, USP 0.3%, 5mL bottles, Rx only, Manufactured by: Akorn , Inc, Lake Forest, IL 60045. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0848-202304-26-202306-07-2023Class IIN/ASulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL, 473 mL bottles, Cherry Flavor, Rx only, Manufactured by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0793-202304-26-202306-07-2023Class IIN/ACimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0801-202304-26-202306-07-2023Class IIN/ADOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10mL Unit Dose cups, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0804-202304-26-202306-07-2023Class IIN/AFluticasone Propionate Nasal Spray, 50mcg, 16 g bottles, Manufactured by: HI-TECH PHARMACAL CO., INC., Amiy. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0788-202304-26-202306-07-2023Class IIN/AAK-POLY-BAC (bacitracin Zinc and Polymyxin B Sulfate) Ophthalmic Ointment, 3.5g, Sterile, Rx Only, For Ophthalmic Use Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0800-202304-26-202306-07-2023Class IIN/ADiuril (chlorothiazide sodium) Injection, 500mg/vial, Single-Dose Vial, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0836-202304-26-202306-07-2023Class IIN/APrednisolone Oral Solution, USP, 15 mg/5 mL, packaged in a) 240 mL and b) 480 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0860-202304-26-202306-07-2023Class IIN/AOlopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0857-202304-26-202306-07-2023Class IIN/AAmantadine Hydrochloride Oral Solution USP, 50mg/5mL, 473mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0861-202304-26-202306-07-2023Class IIN/APilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0850-202304-26-202306-07-2023Class IIN/ATobramycin Inhalation Solution USP, 300 mg/5 mL, 4 single-dose ampules, Rx only, Manufactured by: Akorn, Inc, Lake Forest, IL 60045. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0814-202304-26-202306-07-2023Class IIN/ALactulose Solution, USP (Oral), 10g/15 mL, packaged in a) 15mL bottles, b) 30 mL bottles, c) 473 mL bottles, and d) 946 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0849-202304-26-202306-07-2023Class IIN/ATimolol Maleate Ophthalmic Solution, USP 0.5%, packaged in a) 2.5mL bottles, b) 5mL bottles, c) 10 mL bottles, and d)15mL bottles, Rx only, Manufactured by: Akorn , Inc, Lake Forest, IL 60045. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0790-202304-26-202306-07-2023Class IIN/ACalcitriol Injection 1 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0787-202304-26-202306-07-2023Class IIN/AAzelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, For Intranasal Use Only, Manufactured by: Hi-Tech Pharmacal Co., INC., Amityville, NY 11701. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0825-202304-26-202306-07-2023Class IIN/ALorazepam Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0830-202304-26-202306-07-2023Class IIN/ANaloxone Injection, USP 0.4 mg/mL, For Intravenous, Intramuscular or Subcutaneous Use, 1 mL vials, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0799-202304-26-202306-07-2023Class IIN/ADicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) ampules, 2 mL ampules, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0826-202304-26-202306-07-2023Class IIN/ALorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0846-202304-26-202306-07-2023Class IIN/ASodium DIURIL (chlorothiazide sodium), 0.5g/vial, Single-dose vial Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0829-202304-26-202306-07-2023Class IIN/AMoxifloxacin HCl Ophthalmic Solution, USP, 0.5%, 3 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0827-202304-26-202306-07-2023Class IIN/AMegestrol Acetate Oral Suspension, USP 40 mg/mL, 240 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0841-202304-26-202306-07-2023Class IIN/ARifampin Capsules USP, 300 mg, packaged in a) 30 count bottles and b) 60 count bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0812-202304-26-202306-07-2023Class IIN/AIC-Green (indocyanine green for injection, USP) 25 mg/10 mL Kit, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0794-202304-26-202306-07-2023Class IIN/AClobetasol Propionate Cream, USP, 0.05%, packaged in a) 15g tubes, b) 30g tubes, and c) 60g tubes, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0819-202304-26-202306-07-2023Class IIN/ALevofloxacin Oral Solution, 25 mg/mL, packaged in a) 100 mL bottles, b) 200 mL bottles, and c) 480 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0795-202304-26-202306-07-2023Class IIN/AClobetasol Propionate Ointment, USP, 0.05%, 15 g tubes, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0808-202304-26-202306-07-2023Class IIN/AGuaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free, Rx Only, For Institutional Use Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0802-202304-26-202306-07-2023Class IIN/AEphedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Intravenous Use, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0824-202304-26-202306-07-2023Class IIN/ALidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0779-202304-26-202306-07-2023Class IIN/AAtropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL bottles, and C) 15 mL bottles, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0791-202304-26-202306-07-2023Class IIN/ACetrorelix Acetate for Injection, 0.25 mg, , One carton contains one packaged tray which contains: 1 vial with lyophilized powder for reconstitution, 1 pre-filled syringe with diluent, 1 20-gauge needle, 1 27-gauge needle, Sterile - For subcutaneous use only, Rx Only, Manufactured by: GP Pharm S.A. Barcelona, Spain (ESP) -08777, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0797-202304-26-202306-07-2023Class IIN/ACromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0815-202304-26-202306-07-2023Class IIN/ALactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0780-202304-26-202306-07-2023Class IIN/AAcetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a) 473mL bottles and b) 40 UD cups, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0816-202304-26-202306-07-2023Class IIN/ALevetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0845-202304-26-202306-07-2023Class IIN/ASodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL, 15 mL bottles, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0856-202304-26-202306-07-2023Class IIN/AXOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1.25mg/3mL, 0.5 mL unit-dose vials, Rx only, Distributed by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0855-202304-26-202306-07-2023Class IIN/AVitamin D Supplement Drops, 400 IU, Cherry Flavored 50mL bottle, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0838-202304-26-202306-07-2023Class IIN/APromethazine HCl Oral Solution, USP, 6.25 mg/5mL, 473 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0832-202304-26-202306-07-2023Class IIN/AOlopatadine HCl Nasal Spray, 665 mcg, 30.5 g bottles, Rx Only, Manufactured by: Akorn, Operating Company LLC, Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0785-202304-26-202306-07-2023Class IIN/AArtificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0863-202304-26-202306-07-2023Class IIN/ARopivacaine Hydrochloride Injection USP, 0.2%, 200mg/100 mL (2 mg/mL), 100 mL Vial, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0843-202304-26-202306-07-2023Class IIN/AFentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL), Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0823-202304-26-202306-07-2023Class IIN/ALidocaine HCl Jelly USP, 2%, 5mL tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0807-202304-26-202306-07-2023Class IIN/AGuaiatussin AC Sugar-Free, Each teaspoonful (5 mL) contains: Guaifenesin (100 mg), Codeine Phosphate (10 mg), Alcohol (3.5% v/v), a) packaged in a) 118 mL bottles, b) 473 mL bottles and c) 100 unit dose cups, Rx Only, Distributed by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0842-202304-26-202306-07-2023Class IIN/ARopivacaine Hydrochloride Injection USP, 0.5%, 150mg/30 mL (5 mg/mL), 30 mL Single-dose Vial, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0852-202304-26-202306-07-2023Class IIN/ATrihexyphenidyl Hydrochloride Oral Solution, USP, 2mg/5mL, 473 mL bottles, Rx only, Distributed by: VersaPharm, Inc. - An Akorn Company- Lake Forest, IL 60045. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0847-202304-26-202306-07-2023Class IIN/ASufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL, packaged in a)1 mL ampules, b) 2mL ampules, c) 5mL ampules, For Intravenous and Epidural Use, Rx only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0853-202304-26-202306-07-2023Class IIN/ATropicamide Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0818-202304-26-202306-07-2023Class IIN/ALevofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, packaged in a) 20mL vials and b) 30 mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0831-202304-26-202306-07-2023Class IIN/ANeomycin & Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, 3.5 g tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0844-202304-26-202306-07-2023Class IIN/ASodium Chloride Ophthalmic Ointment, USP, 5%, 3.5g tubes, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0783-202304-26-202306-07-2023Class IIN/AAlbuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0792-202304-26-202306-07-2023Class IIN/ACiclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0834-202304-26-202306-07-2023Class IIN/AOxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0786-202304-26-202306-07-2023Class IIN/AArtificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram tubes, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0784-202304-26-202306-07-2023Class IIN/AApraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottles, Rx only, Sterile, For Topical Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0810-202304-26-202306-07-2023Class IIN/AHydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0811-202304-26-202306-07-2023Class IIN/AHydromorphone Hydrochloride Injection, USP, 50mg/5mL (10 mg/mL) packaged in a) 1 mL ampules, b) 5 mL ampules, c) 50 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0837-202304-26-202306-07-2023Class IIN/APromethazine HCl & Codeine Phosphate Oral Solution, USP, 6.25mg/10mg per 5 mL, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0798-202304-26-202306-07-2023Class IIN/ADetomiSed (detomidine hydrochloride) packaged in a) 5mL and b)20mL vials, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0782-202304-26-202306-07-2023Class IIN/AAcyclovir Oral Suspension, 200mg/5mL, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0805-202304-26-202306-07-2023Class IIN/AGonak Hypromellose Ophthalmic Solution 25mg/mL, 15 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing
D-0822-202304-26-202306-07-2023Class IIN/ALidocaine Ointment USP, 5%, 1 1/4 oz tubes, Rx Only, Manufactured for: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. ALL NDCsCGMP Deviations: Firm went out of business and could no longer continue stability studies.Ongoing