Home / Recalls / Akorn Inc / D-1090-2017

D-1090-2017 Class III Terminated

Recalled by Akorn Inc — Lake Forest, IL

Recall Details

Product Type
Drugs
Report Date
August 23, 2017
Initiation Date
July 12, 2017
Termination Date
June 19, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
101,952 15 mL unit dose cups

Product Description

Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97014

Reason for Recall

Crystallization with subpotent out of specification assay results for chlorhexidine.

Distribution Pattern

Nationwide in the USA

Code Information

Lots: 0202635072, 0202635073, EXP 06-2018; 0202630205, 0202630206, EXP 07-2018; 0202630203, 0202630204, 0202642217, 0202642218, 0202642219, 0202647410, 0202647411, EXP 08-2018; 0202647409, 0202647412, 0202653431, 0202653432, EXP 09-2018.

Other recalls by Akorn Inc

  • D-0829-2023 Class II — Moxifloxacin HCl Ophthalmic Solution, USP, 0.5%, 3 mL bottles, Rx Only, Manufac (April 26, 2023)
  • D-0803-2023 Class II — Ferrous Sulfate Iron Supplement Drops, packaged in 50 mL bottles, Distributed by (April 26, 2023)
  • D-0785-2023 Class II — Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, Dist (April 26, 2023)
  • D-0793-2023 Class II — Cimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles, Rx Only, Distributed by: (April 26, 2023)
  • D-0821-2023 Class II — Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes, Rx Only, Manufactured by: (April 26, 2023)
  • D-0827-2023 Class II — Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 mL bottles, Rx Only, Distri (April 26, 2023)
  • D-0820-2023 Class II — Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured by: (April 26, 2023)
  • D-0860-2023 Class II — Olopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles, Rx Only, Sterile, M (April 26, 2023)
  • D-0845-2023 Class II — Sodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL, 15 mL bottles, Distribute (April 26, 2023)
  • D-0854-2023 Class II — Valproic Acid Oral Solution, USP, 250mg/5mL, 473 mL bottles, Rx only, Distribu (April 26, 2023)