Home / Recalls / Akorn, Inc. / D-0613-2018

D-0613-2018 Class III Terminated

Recalled by Akorn, Inc. — Lake Forest, IL

Recall Details

Product Type
Drugs
Report Date
April 4, 2018
Initiation Date
March 29, 2018
Termination Date
April 22, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20,587 unit dose cups

Product Description

24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701; Kit Manufactured by Halyard Health, Inc., 5405 Windward Parkway, Alpharetta, GA 30004; Distributed in the USA by Halyard Sales, LLC, Alpharetta, GA 30004, Product 97014.

Reason for Recall

Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.

Distribution Pattern

Nationwide in the USA

Code Information

Chlorhexidine Gluconate Oral Rinse lot # 350836, Exp 05/18 contained within kit lot #: 0202522468, 0202522470, Exp 03/18; 0202518966, 0202522469, 0202522471, 0202533449, 0202533456, 0202533463, 0202543351, 0202548200, Exp 04/18

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)