Akorn, Inc. recalls
63 recalls on record · FDA
Every recall we have on record for Akorn, Inc., compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
Showing the 60 most recent of 63 Akorn, Inc. recalls.
Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, packaged in a)…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Clobetasol Propionate Cream, USP, 0.05%, packaged in a) 15g tubes, b) 30g tubes, and c)…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured by: Akorn,…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Tropicamide Ophthalmic Solution, USP 0.1%, 15 mL bottles, Rx only, Distributed by: Akorn…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Calcitriol Injection 1 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Sodium Chloride Ophthalmic Ointment, USP, 5%, 3.5g tubes, Manufactured by: Akorn Inc.,…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, For Intranasal…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Levocarnitine Oral Solution, USP, 118 mL bottles, Rx Only, Distributed by: Akorn, Inc.,…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles, Rx Only, Distributed by:…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Artificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram tubes, Distributed…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes, Rx Only, Manufactured by: HI-TECH…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 mL bottles, Rx Only, Distributed by:…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Ferrous Sulfate Iron Supplement Drops, packaged in 50 mL bottles, Distributed by: Akorn…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, Distributed…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Olopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles, Rx Only, Sterile,…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Clobetasol Propionate Ointment, USP, 0.05%, 15 g tubes, Rx Only, Distributed by: Akorn…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Rifampin Capsules USP, 300 mg, packaged in a) 30 count bottles and b) 60 count bottles, …
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Intravenous…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Ropivacaine Hydrochloride Injection USP, 0.2%, 200mg/100 mL (2 mg/mL), 100 mL Vial, Rx…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye,…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
AK-POLY-BAC (bacitracin Zinc and Polymyxin B Sulfate) Ophthalmic Ointment, 3.5g, Sterile,…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile, Manufactured by:…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Naloxone Injection, USP 0.4 mg/mL, For Intravenous, Intramuscular or Subcutaneous Use, 1…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles, Rx Only, Manufactured by:…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
IC-Green (indocyanine green for injection, USP) 25 mg/10 mL Kit, Rx Only, Sterile,…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Amantadine Hydrochloride Oral Solution USP, 50mg/5mL, 473mL bottles, Rx only, Distributed…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 mL bottles, Rx Only, Sterile,…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Levofloxacin Oral Solution, 25 mg/mL, packaged in a) 100 mL bottles, b) 200 mL bottles,…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) ampules, 2 mL ampules, Rx…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Diuril (chlorothiazide sodium) Injection, 500mg/vial, Single-Dose Vial, Rx Only,…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL), Rx Only, Manufactured by: Akorn…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Prednisolone Oral Solution, USP, 15 mg/5 mL, packaged in a) 240 mL and b) 480 mL bottles,…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Valproic Acid Oral Solution, USP, 250mg/5mL, 473 mL bottles, Rx only, Distributed by:…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Tobramycin Inhalation Solution USP, 300 mg/5 mL, 4 single-dose ampules, Rx only,…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Tobramycin Ophthalmic Solution, USP 0.3%, 5mL bottles, Rx only, Manufactured by: Akorn ,…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free, Rx Only, For…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottles, Rx only,…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a) 473mL…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes, Rx Only,…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Lidocaine HCl Jelly USP, 2%, 5mL tubes, Rx Only, Manufactured by: Akorn, Inc., Lake…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed by:…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Sodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL, 15 mL bottles, Distributed by:…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one packaged tray which…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials, For Intramuscular or…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufactured by: …
CGMP Deviations:
Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-711-10) x10…
CGMP Deviations:
Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Manufactured by:…
CGMP Deviations:
GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dropper bottle,…
CGMP Deviations:
Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn,…
CGMP Deviations:
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper bottle,…
CGMP Deviations:
Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per dropper bottle, Rx Only, …
CGMP Deviations:
Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Manufactured…
CGMP Deviations:
Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tube, …
CGMP Deviations:
Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manufactured by:…
CGMP Deviations:
Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit-dose tubes…
CGMP Deviations:
Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per bottle,…
CGMP Deviations:
Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating…
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by:…
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by:…
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amber glass…
Defective container: defect prevents product from dispensing as intended.