Akorn Issues Voluntary Nationwide Recall of Various Human and Animal Drug Products Within Expiry Due to Company Shutdown
On April 26, 2023, Akorn Operating Company LLC has initiated a voluntary recall of various within-expiry human products as a result of the closures and discontinuation of the Quality activities of these marketed products. The discontinuation of the Quality program would result in the company's inability to assure that products meet the identity, strength, quality, and purity characteristics. While specific risks to patients cannot always be identified or assessed, there is still a potential risk from using the products. Akorn has not received any reports of adverse events related to this recall.
Product | Lot |
---|---|
Acetaminophen & Codeine Phosphate Oral Solution 120mg & 12mg/5mL | All NDCs and All Lots |
Acetic Acid Otic Solution | All NDCs and All Lots |
Acyclovir Oral Suspension, 200mg/5mL | All NDCs and All Lots |
Albuterol Sulfate Syrup, 2mg (base) | All NDCs and All Lots |
Amantadine HCl Syrup, USP 50 mg per 5mL | All NDCs and All Lots |
Apraclonidine Ophthalmic Solution 0.5% | All NDCs and All Lots |
Artificial Tears | All NDCs and All Lots |
Atropine Sulfate Ophthalmic Solution | All NDCs and All Lots |
Azelastine Hydrochloride Nasal Spray, 0.1% | All NDCs and All Lots |
Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, 3.5g | All NDCs and All Lots |
Calcipotriene Scalp Solution, 0.005% | All NDCs and All Lots |
Calcitriol Injection 1 mcg and 2 mcg | All NDCs and All Lots |
Cetrorelix Acetate for Injection, 0.25 mg/vial, Single-Dose Vial | All NDCs and All Lots |
Ciclopirox Topical Solution 8% | All NDCs and All Lots |
Cimetidine HCl Oral Solution | All NDCs and All Lots |
Clobetasol Propionate Cream 0.05% | All NDCs and All Lots |
Clobetasol Propionate Ointment, 0.05% | All NDCs and All Lots |
Clobetasol Propionate Shampoo, 0.05% | All NDCs and All Lots |
Cromolyn Sodium Ophthalmic Solution 4% | All NDCs and All Lots |
Detomidine Hydrochloride 20mL and 5mL | All NDCs and All Lots |
Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) | All NDCs and All Lots |
Diuril® (chlorothiazide sodium) Injection | All NDCs and All Lots |
DOCU LIQUID- docusate sodium liquid | All NDCs and All Lots |
Ephedrine Injection 50 mg/mL | All NDCs and All Lots |
Ferrous Sulfate Elixir and Iron Supplement | All NDCs and All Lots |
Fluticasone Propionate Nasal Spray | All NDCs and All Lots |
Gonak Hypromellose Ophth Sol | All NDCs and All Lots |
Granisetron HCl Injection 1 mg/mL | All NDCs and All Lots |
Guaifenesin and Codeine Phosphate Liquid | All NDCs and All Lots |
HydrALAZINE HCl Injection | All NDCs and All Lots |
Hydrocortisone and Acetic Acid Otic Solution | All NDCs and All Lots |
Hydromorphone High Potency Injection USP – Ampule and Vial | All NDCs and All Lots |
IC-Green Sterile Indocyanine Green Injection USP | All NDCs and All Lots |
Ketorolac Tromethamine Ophthalmic Solution, 0.5% | All NDCs and All Lots |
Lactulose Syrup (Oral) and (Oral/Rectal) | All NDCs and All Lots |
Levetiracetam Injection USP, 500 mg/5 mL (100 mg/mL) single-dose vial | All NDCs and All Lots |
Levocarnitine Oral Solution, USP | All NDCs and All Lots |
Levofloxacin Injection, 25 mg/mL | All NDCs and All Lots |
Levofloxacin Oral Solution | All NDCs and All Lots |
Levofloxacin Opth Solution | All NDCs and All Lots |
Lidocaine 2.5% & Prilocaine 2.5% Cream | All NDCs and All Lots |
Lidocaine Ointment | All NDCs and All Lots |
Lidocaine HCl Jelly USP, 2% | All NDCs and All Lots |
Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% | All NDCs and All Lots |
Lorazepam Injection 2 mg/mL vial | All NDCs and All Lots |
Lorazepam Oral Concentrate, 2mg | All NDCs and All Lots |
Megestrol Acetate Oral Suspension 40 mg/mL | All NDCs and All Lots |
Midazolam Injection USP 1 mg/mL & 5 mg/mL - vial | All NDCs and All Lots |
Moxifloxacin HCl Solution 0.5% | All NDCs and All Lots |
Naloxone Injection 0.4 mg/mL; 1 mL and 10mL Vial | All NDCs and All Lots |
Neomycin & Polymyxin B Sulfates & Bacitracin Zinc Ophthalmic Ointment | All NDCs and All Lots |
Olopatadine HCl Nasal Spray, 665 mcg/spray | All NDCs and All Lots |
Olopatadine Solution 0.1% and 0.2% | All NDCs and All Lots |
Oxcarbazepine Oral Suspension USP, 300 mg/5 mL | All NDCs and All Lots |
Pilocarpine 1, 2, & 4% | All NDCs and All Lots |
Prednisolone Sodium Phosphate Oral Solution | All NDCs and All Lots |
Promethazine HCl & Codeine Phosphate Oral Solution | All NDCs and All Lots |
Promethazine HCl Oral Solution | All NDCs and All Lots |
Proparacaine HCl Ophthalmic Solution, 0.5% | All NDCs and All Lots |
Rifampin Capsules USP, 150 mg & 300 mg | All NDCs and All Lots |
Ropivacaine Hydrochloride Injection USP, 0.2% and 5mg/mL | All NDCs and All Lots |
Fentanyl Citrate Injection | All NDCs and All Lots |
Sodium Chloride Ophthalmic Ointment | All NDCs and All Lots |
Sodium Chloride Solution Drops | All NDCs and All Lots |
Sodium DIURIL | All NDCs and All Lots |
Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL | All NDCs and All Lots |
Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL | All NDCs and All Lots |
Timolol Maleate Ophthalmic Solution 0.5%, 2.5, 5, 10, & 15mL | All NDCs and All Lots |
Tobramycin Inhalation Solution USP, 300 mg/5 mL | All NDCs and All Lots |
Tobramycin Ophthalmic Solution 0.3% | All NDCs and All Lots |
Trihexyphenidyl HCl Oral Sol | All NDCs and All Lots |
Tropicamide Ophthalmic Solution 0.5% and 1% | All NDCs and All Lots |
Valproic Acid Oral Solution | All NDCs and All Lots |
Vitamin D Suppl. Drops 50mL | All NDCs and All Lots |
XOPENEX- levalbuterol hydrochloride solution, concentrate | All NDCs and All Lots |
If you have any of the recalled products, you should discard the product and contact your doctor. You should contact your physician or healthcare provider if you have any questions or concerns.
For questions regarding this recall can contact Akorn at (800) 932-5676, Monday – Friday, 8am – 5pm CDT.
Source:
- FDA MedWatch. “Recalls, Market Withdrawals, & Safety Alerts”. Retrieved May 1, 2023 from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/akorn-issues-voluntary-nationwide-recall-various-human-and-animal-drug-products-within-expiry-due?utm_medium=email&utm_source=govdelivery