Akorn Operating Company, LLC has declared bankruptcy and discontinued all operations including their quality program. This has resulted in an inability to identify if products being distributed to the public are safe for consumption and use. Products could be contaminated with unintended substances, could vary in strength, or could contain other quality discrepancies that may affect the health of those who receive them. Therefore, all of their products are being recalled immediately. As of the writing of this notice, no adverse effects have yet been reported.
SUMMARY
Date of Recall:
Announced: April 26, 2023
Public Notification: April 26, 2023
Name(s) of Drug:
See Chart Below
Company Name:
Akorn Operating Company, LLC
Drug Indication:
See Chart Below
Product Description
See Chart Below
Reason for Recall
Quality control measures are imperative in maintaining the appropriate strength and specifications of each medication. Without it, medications may contain harmful substances or discrepancies in quality control that can affect the way the medications react within the human or animal body. No adverse effects have yet been reported and at this time this recall is being issued out of caution only.
Impacts
Consumers who utilize the medications listed may be receiving a higher or lower dose than indicated, or could be ingesting substances that have contaminated the medications during the manufacturing process. This could lead to serious health outcomes including (but not limited to) allergic reactions, increase or decrease in underlying symptoms, organ damage, or even death.
Lot information
For each medication listed, all NDCs and all lots are being recalled. Each medication was packaged by Akorn. If your medication was produced or packaged elsewhere, it is not currently part of this particular recall. All listed medications, even if they are not currently expired, are included in the recall.
Medications were distributed nationwide through wholesalers, retailers, medical facilities and online sellers. Please check all of your medications.
HUMAN PRODUCTS
| Description |
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 |
| 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 |
ANIMAL PRODUCTS
| Product Description |
Lot |
| Artificial Tears | All NDCs and All Lots |
| Atropine Sulfate Ophthalmic Solution | All NDCs and All Lots |
| Butorphic Injection (butorphanol tartrate), 10 mg/mL | All NDCs and All Lots |
| Detomidine Hydrochloride 20mL and 5mL | All NDCs and All Lots |
| KETAMINE- ketamine hydrochloride injection, solution | All NDCs and All Lots |
| Neomycin & Polymyxin B Sulfates & Bacitracin Zinc Ophthalmic Ointment | All NDCs and All Lots |
| Proparacaine HCl Ophthalmic Solution, 0.5% | All NDCs and All Lots |
| Tobramycin Ophthalmic Solution 0.3% | All NDCs and All Lots |
| Vetaket 100 mg/mL Injection (ketamine HCl) | All NDCs and All Lots |
| VETORPHIC- butorphanol tartrate injection, solution | All NDCs and All Lots |
Have you found that your medication is part of the recall?
Here’s what you should do:
Consumers
If you find that your lot of supplements is part of this recall, do the following:
- DO NOT DISCONTINUE USE OF THE MEDICATION UNTIL YOU HAVE SPOKEN TO YOUR PHYSICIAN OR VETERINARIAN. SOME MEDICATIONS HAVE SERIOUS SIDE EFFECTS WHEN STOPPED SUDDENLY. NOTIFY YOUR PHYSICIAN/VETERINARIAN IMMEDIATELY IF YOUR MEDICATION IS INCLUDED IN THE RECALL.
- Request a replacement prescription from your physician.
- Notify your physician/veterinarian if you or your pet has utilized the medication and have experienced any of the symptoms listed above.
- Continue to monitor your health and the health of any pets who have received listed medications for any adverse symptoms over the next week and notify your physician/veterinarian if any concerns are noted.
- Consumers may request a refund from the location at which they purchased their product. They may also contact the manufacturer by telephone at 1-800-932-5676. They are available Monday-Friday from 8am-5pm (CDT).
- If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form. For pets who experience an adverse reaction, the FDA reporting form can be found here.
- Contact MedWaste Management for information and/or assistance with disposing of the recalled supplement.
Retailer
- Examine all inventory and remove stock that is affected by the recall immediately.
- Contact the manufacturer by telephone at 1-800-932-5676. They are available Monday-Friday from 8am-5pm (CDT). Notify them of any recalled batches that have already been sold to consumers.
- Notify affected consumers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and/or assistance with disposing of the recalled supplement.
Wholesaler
- Examine all inventory and remove stock that is affected by the recall immediately.
- Contact the manufacturer by telephone at 1-800-932-5676. They are available Monday-Friday from 8am-5pm (CDT). Notify them of any recalled batches that have already been shipped to retailers.
- Notify affected retailers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and/or assistance with disposing of the recalled supplement.
We are MedWaste Management – California’s medical waste disposal experts!
Established in 2008, MedWaste Management fills a need for compliant and safe medical waste disposal to the healthcare industry and the general public alike. We publish this blog in order to spread useful and practical information to help you stay safe, smart and healthy!
Call us with any questions or to start service at (866) 254-5105. We are always happy to help!
Check out our services and other great resources in the links below.
Medical Waste Disposal Services
Learn How To Properly Manage & Dispose of Household Medical Waste