Akorn Recalls Various Drug Products Due to Company Shutdown

Akorn has initiated a voluntary recall of various within-expiry drug products as the company has shut down operations and is unable to assure the quality of the products.

The recalled products were distributed nationwide to wholesalers, retailers, manufacturers, medical facilities, and repackagers and via the Internet to consumers. The discontinuation of the Company’s Quality program means that it is unable to support or guarantee that the medications will meet all intended specifications through the labeled shelf life of the product.

All NDCs and Lots of the following Akorn products have been recalled:

• Acetaminophen & Codeine Phosphate Oral Solution 120mg & 12mg/5mL
• Acetic Acid Otic Solution
• Acyclovir Oral Suspension, 200mg/5mL
• Albuterol Sulfate Syrup, 2mg (base)
• Amantadine HCl Syrup, USP 50mg per 5mL
• Apraclonidine Ophthalmic Solution 0.5%
• Artificial Tears
• Atropine Sulfate Ophthalmic Solution
• Azelastine Hydrochloride Nasal Spray, 0.1%
• Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, 3.5g
• Calcipotriene Scalp Solution, 0.005%
• Calcitriol Injection 1mcg and 2mcg
• Cetrorelix Acetate for Injection, 0.25mg/vial, Single-Dose Vial
• Ciclopirox Topical Solution 8%
• Cimetidine HCl Oral Solution
• Clobetasol Propionate Cream 0.05%
• Clobetasol Propionate Ointment, 0.05%
• Clobetasol Propionate Shampoo, 0.05%
• Cromolyn Sodium Ophthalmic Solution 4%
• Detomidine Hydrochloride 20mL and 5mL
• Dicyclomine Hydrochloride Injection USP, 20mg/2 mL (10mg/mL)
• Diuril^® (chlorothiazide sodium) Injection
• DOCU LIQUID- docusate sodium liquid
• Ephedrine Injection 50mg/mL
• Fentanyl Citrate Injection
• Ferrous Sulfate Elixir and Iron Supplement
• Fluticasone Propionate Nasal Spray
• Gonak Hypromellose Ophth Sol
• Granisetron HCl Injection 1mg/mL
• Guaifenesin and Codeine Phosphate Liquid
• Hydralazine HCl Injection
• Hydrocortisone and Acetic Acid Otic Solution
• Hydromorphone High Potency Injection USP – Ampule and Vial
• IC-Green Sterile Indocyanine Green Injection USP
• Ketorolac Tromethamine Ophthalmic Solution, 0.5%
• Lactulose Syrup (Oral) and (Oral/Rectal)
• Levetiracetam Injection USP, 500mg/5 mL (100mg/mL) single-dose vial
• Levocarnitine Oral Solution, USP
• Levofloxacin Injection, 25mg/mL
• Levofloxacin Oral Solution
• Levofloxacin Opth Solution
• Lidocaine 2.5% & Prilocaine 2.5% Cream
• Lidocaine Ointment
• Lidocaine HCl Jelly USP, 2%
• Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%
• Lorazepam Injection 2mg/mL vial
• Lorazepam Oral Concentrate, 2mg
• Megestrol Acetate Oral Suspension 40mg/mL
• Midazolam Injection USP 1mg/mL & 5mg/mL – vial
• Moxifloxacin HCl Solution 0.5%  
• Naloxone Injection 0.4mg/mL; 1mL and 10mL Vial
• Neomycin & Polymyxin B Sulfates & Bacitracin Zinc Ophthalmic Ointment
• Olopatadine HCl Nasal Spray, 665mcg/spray
• Olopatadine Solution 0.1% and 0.2%   
• Oxcarbazepine Oral Suspension USP, 300mg/5 mL
• Pilocarpine 1, 2, & 4%         
• Prednisolone Sodium Phosphate Oral Solution
• Promethazine HCl & Codeine Phosphate Oral Solution
• Promethazine HCl Oral Solution
• Proparacaine HCl Ophthalmic Solution, 0.5%
• Rifampin Capsules USP, 150mg & 300mg
• Ropivacaine Hydrochloride Injection USP, 0.2% and 5mg/mL
• Sodium Chloride Ophthalmic Ointment
• Sodium Chloride Solution Drops
• Sodium DIURIL
• Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL
• Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL
• Timolol Maleate Ophthalmic Solution 0.5%, 2.5, 5, 10, & 15mL
• Tobramycin Inhalation Solution USP, 300mg/5 mL
• Tobramycin Ophthalmic Solution 0.3%
• Trihexyphenidyl HCl Oral Sol
• Tropicamide Ophthalmic Solution 0.5% and 1%
• Valproic Acid Oral Solution
• Vitamin D Suppl. Drops 50mL
• Xopenex– levalbuterol hydrochloride solution, concentrate

Further distribution or use of these recalled products should be discontinued immediately. To date, the Company has not received any reports of adverse events related to this recall.

Adverse events or quality issues should be reported to the FDA’s MedWatch Adverse Event Reporting program. Consumers with questions regarding this recall can contact Akorn at (800) 932-5676.