Akorn, Inc. Provisional
FDA Flags (130)
Class II RecallJun 2023
Akorn, Inc.
Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, packaged in a) 20mL vials and b) 30 mL vials, R
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Clobetasol Propionate Cream, USP, 0.05%, packaged in a) 15g tubes, b) 30g tubes, and c) 60g tubes, Rx Only, Distributed
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Tropicamide Ophthalmic Solution, USP 0.1%, 15 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee,
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Calcitriol Injection 1 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. A
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Sodium Chloride Ophthalmic Ointment, USP, 5%, 3.5g tubes, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, For Intranasal Use Only, Manufactured by: Hi-
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Levocarnitine Oral Solution, USP, 118 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., G
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Artificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram tubes, Distributed by: Akorn Operating Company LLC
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes, Rx Only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC.,
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Ferrous Sulfate Iron Supplement Drops, packaged in 50 mL bottles, Distributed by: Akorn Operating Company LLC, Gurnee, I
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC,
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Olopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Clobetasol Propionate Ointment, USP, 0.05%, 15 g tubes, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee,
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Rifampin Capsules USP, 300 mg, packaged in a) 30 count bottles and b) 60 count bottles, Rx Only, Distributed by: Akorn
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Intravenous Use, Rx Only, Distributed by: Akor
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Ropivacaine Hydrochloride Injection USP, 0.2%, 200mg/100 mL (2 mg/mL), 100 mL Vial, Rx Only, Manufactured by: Akorn Inc.
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL bo
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
AK-POLY-BAC (bacitracin Zinc and Polymyxin B Sulfate) Ophthalmic Ointment, 3.5g, Sterile, Rx Only, For Ophthalmic Use On
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 6004
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Naloxone Injection, USP 0.4 mg/mL, For Intravenous, Intramuscular or Subcutaneous Use, 1 mL vials, Rx only, Manufactured
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
IC-Green (indocyanine green for injection, USP) 25 mg/10 mL Kit, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Fo
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Amantadine Hydrochloride Oral Solution USP, 50mg/5mL, 473mL bottles, Rx only, Distributed by: Akorn Operating Company LL
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Levofloxacin Oral Solution, 25 mg/mL, packaged in a) 100 mL bottles, b) 200 mL bottles, and c) 480 mL bottles, Rx Only,
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) ampules, 2 mL ampules, Rx Only, Distributed by: Akorn Op
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Diuril (chlorothiazide sodium) Injection, 500mg/vial, Single-Dose Vial, Rx Only, Distributed by: Akorn Operating Company
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL), Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. AL
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Prednisolone Oral Solution, USP, 15 mg/5 mL, packaged in a) 240 mL and b) 480 mL bottles, Rx Only, Distributed by: Akorn
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Valproic Acid Oral Solution, USP, 250mg/5mL, 473 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gur
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Tobramycin Inhalation Solution USP, 300 mg/5 mL, 4 single-dose ampules, Rx only, Manufactured by: Akorn, Inc, Lake Fores
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Tobramycin Ophthalmic Solution, USP 0.3%, 5mL bottles, Rx only, Manufactured by: Akorn , Inc, Lake Forest, IL 60045. ALL
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free, Rx Only, For Institutional Use Only, Hi-Tech Pharmac
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottles, Rx only, Sterile, For Topical Ophthalmi
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a) 473mL bottles and b) 40 UD cups, Rx only,
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes, Rx Only, Distributed by: Akorn Operating C
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Lidocaine HCl Jelly USP, 2%, 5mL tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Sodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL, 15 mL bottles, Distributed by: Akorn Operating Company LLC, Gurne
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one packaged tray which contains: 1 vial with lyophiliz
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials, For Intramuscular or Intravenous Use, Rx Only, Manufac
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Guaiatussin AC Sugar-Free, Each teaspoonful (5 mL) contains: Guaifenesin (100 mg), Codeine Phosphate (10 mg), Alcohol (3
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL, 473 mL bottles, Cherry Flavor, Rx only, Manufac
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company, L
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 600
Classification: Class II
Class II RecallJun 2023
Akorn, Inc.
Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups, Rx Only, Distributed by: Akorn, Inc.,
Classification: Class II