After Declaring Bankruptcy, Akorn Pulls More Than 50 Medications

Akorn Operating Company, Gurnee, Illinois, filed Chapter 7 bankruptcy and, as a result of the closure of all its sites in the United States and the discontinuation of its quality program, is recalling a slate of within-expiry products.

“The discontinuation of the quality program means the company will not be able to support or guarantee that the products will meet all intended specifications through the labeled shelf life of the product,” the company stated in an April 26, 2023, announcement. “Further distribution or use of any remaining product on the market should cease immediately.”

According to the June 7, 2023, US Food and Drug Administration (FDA) Enforcement Report, the recalls have been designated Class II, indicating that use of the products could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

The recall includes all NDCs and lots of the following products, which were distributed nationwide to wholesalers, retailers, manufacturers, medical facilities, repackagers, and consumers:

•    acetaminophen & codeine phosphate oral solution,
•    acetic acid otic solution,
•    acyclovir oral suspension,
•    AK-POLY-BAC (bacitracin zinc and polymyxin b sulfate) ophthalmic ointment,
•    albuterol sulfate syrup,
•    amantadine hydrochloride oral solution,
•    apraclonidine ophthalmic solution, 
•    atropine sulfate ophthalmic solution, 
•    azelastine hydrochloride nasal spray,
•    calcipotriene topical solution,
•    cetrorelix acetate for injection,
•    ciclopirox topical solution,
•    cimetidine HCl oral solution,
•    clobetasol propionate cream, 
•    clobetasol propionate shampoo,
•    cromolyn sodium ophthalmic solution, 
•    dicyclomine hydrochloride injection, 
•    Diuril (chlorothiazide sodium) injection,
•    Docu Liquid (docusate sodium, 50 mg/5 mL),
•    ephedrine sulfate injection,
•    fentanyl citrate injection,
•    ferrous sulfate iron supplement drops,
•    GONAK hypromellose ophthalmic solution, 
•    granisetron HCl injection,
•    guaifenesin oral solution,
•    hydrocortisone and acetic acid otic solution,
•    levofloxacin injection,
•    levofloxacin ophthalmic solution,
•    levofloxacin oral solution,
•    lidocaine ointment, 
•    lidocaine HCl jelly,
•    lidocaine hydrochloride oral topical solution,
•    lidocaine 2.5% and prilocaine 2.5% cream,
•    lorazepam oral concentrate,
•    megestrol acetate oral suspension,
•    midazolam injection,
•    naloxone injection,
•    olopatadine HCl nasal spray,
•    olopatadine HCl ophthalmic solution,
•    oxcarbazepine oral suspension,
•    pilocarpine hydrochloride ophthalmic solution,
•    prednisolone oral solution, 
•    promethazine HCl oral solution,
•    promethazine HCl and codeine phosphate oral solution, 
•    proparacaine HCl ophthalmic solution,
•    rifampin capsules,
•    ropivacaine hydrochloride injection,
•    sodium chloride ophthalmic ointment,
•    sodium Diuril (chlorothiazide sodium), 
•    Sufenta (sufentanil citrate injection),
•    timolol maleate ophthalmic solution,
•    tobramycin inhalation solution, and
•    Xopenex (levalbuterol HCl) inhalation solution concentrate.