Recall of Human & Animal Drugs

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 under recall 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:

1. 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.
2. Request a replacement prescription from your physician.
3. Notify your physician/veterinarian if you or your pet has utilized the medication and have experienced any of the symptoms listed above.
4. 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.
5. 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).
6. 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.
7. Contact MedWaste Management for information and/or assistance with disposing of the recalled supplement.

Retailer

1. Examine all inventory and remove stock that is affected by the recall immediately.
2. 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.
3. Notify affected consumers of recalled batches that they have already or will receive.
4. Contact MedWaste Management for information and/or assistance with disposing of the recalled supplement.

Wholesaler

1. Examine all inventory and remove stock that is affected by the recall immediately.
2. 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.
3. Notify affected retailers of recalled batches that they have already or will receive.
4. 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!

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Tammy McKinney, RN, creator of HelpfulHospiceNurse is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or reach out to her directly on LinkedIn!