General Medicine

Akorn Recalls Various Drug Products Due to Company Shutdown

Avatar photoBrian Park, PharmD
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Akorn has initiated a voluntary recall of various within-expiry drug products due to a 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 120 mg & 12 mg/5 mL
  • Acetic Acid Otic Solution
  • Acyclovir Oral Suspension, 200 mg/5 mL
  • Albuterol Sulfate Syrup, 2 mg (base)
  • Amantadine HCl Syrup, USP 50 mg per 5 mL
  • 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, 3.5 g
  • Calcipotriene Scalp Solution, 0.005%
  • Calcitriol Injection 1mcg and 2 mcg
  • Cetrorelix Acetate for Injection, 0.25 mg/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 20 mL and 5 mL
  • Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL)
  • Diuril® (chlorothiazide sodium) Injection
  • DOCU LIQUID- docusate sodium liquid
  • Ephedrine Injection 50 mg/mL
  • Fentanyl Citrate Injection
  • Ferrous Sulfate Elixir and Iron Supplement
  • Fluticasone Propionate Nasal Spray
  • Gonak Hypromellose Ophth Sol
  • Granisetron HCl Injection 1 mg/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, 500 mg/5 mL (100 mg/mL) single-dose vial
  • Levocarnitine Oral Solution, USP
  • Levofloxacin Injection, 25 mg/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 2 mg/mL vial
  • Lorazepam Oral Concentrate, 2 mg
  • Megestrol Acetate Oral Suspension 40 mg/mL
  • Midazolam Injection USP 1 mg/mL & 5 mg/mL – vial
  • Moxifloxacin HCl Solution 0.5%  
  • Naloxone Injection 0.4 mg/mL; 1 mL and 10 mL Vial
  • Neomycin & Polymyxin B Sulfates & Bacitracin Zinc Ophthalmic Ointment
  • Olopatadine HCl Nasal Spray, 665 mcg/spray
  • Olopatadine Solution 0.1% and 0.2%   
  • Oxcarbazepine Oral Suspension USP, 300 mg/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, 150 mg & 300 mg
  • Ropivacaine Hydrochloride Injection USP, 0.2% and 5 mg/mL
  • Sodium Chloride Ophthalmic Ointment
  • Sodium Chloride Solution Drops
  • Sodium DIURIL
  • Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL
  • Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200 mg/40 mg per 5 mL
  • Timolol Maleate Ophthalmic Solution 0.5%, 2.5, 5, 10, & 15 mL
  • Tobramycin Inhalation Solution USP, 300 mg/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 50 mL
  • 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.

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This article originally appeared on MPR

References:

Akorn issues voluntary nationwide recall of various human and animal drug products within expiry due to company shutdown. News release. Akorn. Accessed April 26, 2023. https://www.prnewswire.com/news-releases/akorn-issues-voluntary-nationwide-recall-of-various-human-and-animal-drug-products-within-expiry-due-to-company-shutdown-301808215.html.