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Akorn, Inc. FDA Recalls
131 recalls on file across drugs, 0 of them Class I and 118 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Artificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram tubes, Distributed by: Akorn Operating Company LLCClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALLClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, packaged in a) 20mL vials and b) 30 mL vials, RClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Calcitriol Injection 2 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. AClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL boClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Midazolam Injection, USP 2mg/2mL (1 mg/mL) For Intramuscular or Intravenous Use Only, 2mL vials, Rx Only, Manufactured bClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Calcipotriene Topical Solution, 0.005% (Scalp Solution), 60 mL bottles, Rx Only, Distributed by: Akorn Operating CompanClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 6004Class IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Levofloxacin Oral Solution, 25 mg/mL, packaged in a) 100 mL bottles, b) 200 mL bottles, and c) 480 mL bottles, Rx Only, Class IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| IC-Green (indocyanine green for injection, USP) 25 mg/10 mL Kit, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake FoClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Tobramycin Inhalation Solution USP, 300 mg/5 mL, 4 single-dose ampules, Rx only, Manufactured by: Akorn, Inc, Lake ForesClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Sodium DIURIL (chlorothiazide sodium), 0.5g/vial, Single-dose vial Rx only, Distributed by: Akorn Operating Company LLC,Class IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Neomycin & Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, 3.5 g tubes, Rx Only, Manufactured by: Akorn, Class IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL Class IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Tropicamide Ophthalmic Solution, USP 0.1%, 15 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, Class IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one packaged tray which contains: 1 vial with lyophilizClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC,Class IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Intravenous Use, Rx Only, Distributed by: AkorClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Lidocaine Ointment USP, 5%, 1 1/4 oz tubes, Rx Only, Manufactured for: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701Class IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1.25mg/3mL, 0.5 mL unit-dose vials, Rx only, Distributed by:Class IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Rifampin Capsules USP, 300 mg, packaged in a) 30 count bottles and b) 60 count bottles, Rx Only, Distributed by: Akorn Class IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Ropivacaine Hydrochloride Injection USP, 0.2%, 200mg/100 mL (2 mg/mL), 100 mL Vial, Rx Only, Manufactured by: Akorn Inc.Class IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Proparacaine HCl Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, GurClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Promethazine HCl Oral Solution, USP, 6.25 mg/5mL, 473 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Class IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Clobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., GurClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottles, Rx only, Sterile, For Topical OphthalmiClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 600Class IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Tropicamide Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, Class IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Pilocarpine Hydrochloride Ophthalmic Solution, USP 4%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Class IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Midazolam Injection, USP, 50 mg/10mL (5mg/mL), For Intramuscular or Intravenous Use Only, 10 mL vials, Rx Only, ManufactClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Levocarnitine Oral Solution, USP, 118 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCsClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Acetic Acid Otic Solution, 15 mL per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Class IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, GClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Olopatadine HCl Nasal Spray, 665 mcg, 30.5 g bottles, Rx Only, Manufactured by: Akorn, Operating Company LLC, Gurnee, ILClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Fluticasone Propionate Nasal Spray, 50mcg, 16 g bottles, Manufactured by: HI-TECH PHARMACAL CO., INC., Amiy. ALL NDCsClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Granisetron HCl Injection, USP, 1 mg/mL, packaged in a) 1mL and b) 4 mL vials, Rx Only, For Intravenous Use Only, ManufaClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Timolol Maleate Ophthalmic Solution, USP 0.5%, packaged in a) 2.5mL bottles, b) 5mL bottles, c) 10 mL bottles, and d)15mClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Valproic Acid Oral Solution, USP, 250mg/5mL, 473 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, GurClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free, Rx Only, For Institutional Use Only, Hi-Tech PharmacClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes, Rx Only, Distributed by: Akorn Operating CClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Lidocaine HCl Jelly USP, 2%, 5mL tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCsClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Guaiatussin AC Sugar-Free, Each teaspoonful (5 mL) contains: Guaifenesin (100 mg), Codeine Phosphate (10 mg), Alcohol (3Class IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups, Rx Only, Distributed by: Akorn, Inc.,Class IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Cimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, Class IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Hydromorphone Hydrochloride Injection, USP, 50mg/5mL (10 mg/mL) packaged in a) 1 mL ampules, b) 5 mL ampules, c) 50 mL vClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Rifampin Capsules USP, 150 mg, 30-count bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, Class IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| DOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10mL Unit Dose cups, Distributed by: Akorn OClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Clobetasol Propionate Cream, USP, 0.05%, packaged in a) 15g tubes, b) 30g tubes, and c) 60g tubes, Rx Only, Distributed Class IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., GClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Ferrous Sulfate Iron Supplement Drops, packaged in 50 mL bottles, Distributed by: Akorn Operating Company LLC, Gurnee, IClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Clobetasol Propionate Ointment, USP, 0.05%, 15 g tubes, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, Class IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Calcitriol Injection 1 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. AClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| AK-POLY-BAC (bacitracin Zinc and Polymyxin B Sulfate) Ophthalmic Ointment, 3.5g, Sterile, Rx Only, For Ophthalmic Use OnClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Naloxone Injection, USP 0.4 mg/mL, For Intravenous, Intramuscular or Subcutaneous Use, 1 mL vials, Rx only, ManufacturedClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045Class IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Amantadine Hydrochloride Oral Solution USP, 50mg/5mL, 473mL bottles, Rx only, Distributed by: Akorn Operating Company LLClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Class IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a) 473mL bottles and b) 40 UD cups, Rx only,Class IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Sodium Chloride Ophthalmic Ointment, USP, 5%, 3.5g tubes, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCsClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Sodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL, 15 mL bottles, Distributed by: Akorn Operating Company LLC, GurneClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Prednisolone Oral Solution, USP, 15 mg/5 mL, packaged in a) 240 mL and b) 480 mL bottles, Rx Only, Distributed by: AkornClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, For Intranasal Use Only, Manufactured by: Hi-Class IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials, For Intramuscular or Intravenous Use, Rx Only, ManufacClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031Class IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL, 473 mL bottles, Cherry Flavor, Rx only, ManufacClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Tobramycin Ophthalmic Solution, USP 0.3%, 5mL bottles, Rx only, Manufactured by: Akorn , Inc, Lake Forest, IL 60045. ALLClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company, LClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Vitamin D Supplement Drops, 400 IU, Cherry Flavored 50mL bottle, Distributed by: Akorn Operating Company LLC, Gurnee, ILClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes, Rx Only, Manufactured by: HI-TECH PHARMACAL CO., INC., AmityvilleClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC.,Class IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg/30 mL (5 mg/mL), 30 mL Single-dose Vial, Rx Only, Manufactured by: Class IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Moxifloxacin HCl Ophthalmic Solution, USP, 0.5%, 3 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 6Class IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| DetomiSed (detomidine hydrochloride) packaged in a) 5mL and b)20mL vials, Rx Only, Distributed by: Akorn Operating CompaClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Trihexyphenidyl Hydrochloride Oral Solution, USP, 2mg/5mL, 473 mL bottles, Rx only, Distributed by: VersaPharm, Inc. - Class IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile, packaged in a) 3mL bottles, b bottles) 5 mL, and c)10 mL bottClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Promethazine HCl & Codeine Phosphate Oral Solution, USP, 6.25mg/10mg per 5 mL, Rx Only, Distributed by: Akorn Operating Class IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Lactulose Solution, USP (Oral), 10g/15 mL, packaged in a) 15mL bottles, b) 30 mL bottles, c) 473 mL bottles, and d) 946 Class IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) ampules, 2 mL ampules, Rx Only, Distributed by: Akorn OpClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, Rx only, Distributed by: Akorn Operating Company LLC,Class IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL, packaged in a)1 mL ampules, b) 2mL ampules, c) 5mL ampules, For IClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Acyclovir Oral Suspension, 200mg/5mL, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCsClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Gonak Hypromellose Ophthalmic Solution 25mg/mL, 15 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60Class IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Olopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake ForestClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Diuril (chlorothiazide sodium) Injection, 500mg/vial, Single-Dose Vial, Rx Only, Distributed by: Akorn Operating CompanyClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL), Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALClass IIApr 26, 2023CGMP Deviations: Firm went out of business and could no long |
| Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, DistribClass IIIJan 30, 2023Failed Stability Specifications: Out of specification test r |
| AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3.5 g (1/8 oz.) tube, Rx only, SteriClass IIOct 13, 2022CGMP Deviations: |
| Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 6004Class IIOct 13, 2022CGMP Deviations: |
| Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reliever, 5 mL (0.17 FL OZ) per bottle, ManufacClass IIOct 13, 2022CGMP Deviations: |
| Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Class IIOct 13, 2022CGMP Deviations: |
| Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, Antihistamine and Redness Reliever, ManufacClass IIOct 13, 2022CGMP Deviations: |
| GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dropper bottle, For Professional Use in GoinosClass IIOct 13, 2022CGMP Deviations: |
| Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bottle, Rx Only, Manufactured by: Akorn, Inc.Class IIOct 13, 2022CGMP Deviations: |
| Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 mL (0.5 fl. oz.) per bottle, Sterile, ManufaClass IIOct 13, 2022CGMP Deviations: |
| Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake ForestClass IIOct 13, 2022CGMP Deviations: |
| Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-711-10) x10 per box NDC 17478-711-31; (b) 30Class IIOct 13, 2022CGMP Deviations: |
| Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045. Class IIOct 13, 2022CGMP Deviations: |
| Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tube, Manufactured by: Akorn, Inc., Lake ForClass IIOct 13, 2022CGMP Deviations: |
| Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper bottle, Rx only, Distributed by: Akorn OperClass IIOct 13, 2022CGMP Deviations: |
| Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit-dose tubes per carton), Rx Only, ManufactuClass IIOct 13, 2022CGMP Deviations: |
| Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL Class IIOct 13, 2022CGMP Deviations: |
| Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Class IIOct 13, 2022CGMP Deviations: |
| Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IClass IIOct 13, 2022CGMP Deviations: |
| Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake FoClass IIOct 13, 2022CGMP Deviations: |
| Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per bottle, Sterile, Rx Only, Manufactured by:Class IIOct 13, 2022CGMP Deviations: |
| Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bottle, NDC 17478-288-10; (b) 10 mL droppeClass IIOct 13, 2022CGMP Deviations: |
| Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per bottle, Rx only, Manufactured by: Akorn, Inc., LakeClass IIOct 13, 2022CGMP Deviations: |
| ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube, Rx Only, Manufactured by: Akorn, Inc., LClass IIOct 13, 2022CGMP Deviations: |
| Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper bottle, NDC 17478-209-11; (b) 3 mL droppeClass IIOct 13, 2022CGMP Deviations: |
| Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP, Net Wt. 3.5 g (1/8 oz.), Rx Only, ManuClass IIOct 13, 2022CGMP Deviations: |
| Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 600Class IIOct 13, 2022CGMP Deviations: |
| PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25%, 15 mL per dropper bottle, Rx only, Class IIOct 13, 2022CGMP Deviations: |
| Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle, Rx only, Manufactured by: Akorn, Lake Forest, IL 6Class IIOct 13, 2022CGMP Deviations: |
| Rifampin Capsules, USP, 300 mg, a) 30-count bottle (NDC 61748-018-30), b) 60-count bottle (NDC 61748-018-60), c) 100-couClass IISep 21, 2022Failed impurities/degradation specifications: Finished produ |
| Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031Class IISep 21, 2022Failed impurities/degradation specifications: Finished produ |
| Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL Class IIAug 31, 2022cGMP Deviations: Turbidity discovered in Artificial Tears Oi |
| Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045Class IIAug 31, 2022cGMP Deviations: Turbidity discovered in Artificial Tears Oi |
| Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: AkornClass IIIAug 8, 2022Failed Impurities/Degradation Specifications: Identification |
| PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 1170Class IIAug 1, 2022Defective Container: Product has incomplete induction seals. |
| Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amber glass bottle, Rx only, Manufactured by: Class IIJun 13, 2022Defective container: defect prevents product from dispensing |
| Calcipotriene Topical Solution, 0.005% (Scalp Solution), Rx only, 60 mL (2 fl. oz.) bottle, Manufactured by: HI-TECH PHAClass IIJun 10, 2022Defective Delivery System: Potential defect that could preve |
| Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manufactured by Hi-Tech PhaClass IIIApr 15, 2022Failed viscosity specification - product was below specificc |
| Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural use, Rx only, 2 mL Ampule, WarniClass IIJan 5, 2022Subpotent Drug: Out of specification for assay at the 30-mon |
| Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx only, Manufactured by: Hi-Tech PhaClass IIIDec 3, 2021Labeling: Missing Label |
| Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx only, Hi-Tech Pharmacal Co., Inc., AmityvillClass IIIDec 3, 2021Labeling: Missing Label |
| Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, ManufacturedClass IIOct 4, 2021Microbial Contamination of Sterile Products: Confirmed steri |
| TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 30 Sterile Single-Use Vials per box, Akorn CClass IISep 8, 2021Lack of Assurance of Sterility |
| Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL bottle (NDC 61748-480-30), b) 60 mL bottlClass IIAug 13, 2021Failed impurities/degradation specification: Out of Specific |
| Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, InClass IIAug 2, 2021Non-Sterility - OOS sterility testing observed during 12-mon |
| Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only,Class IIMar 8, 2021Failed Impurities/Degradation Specifications; out of specifi |