Home / Recalls / Akorn, Inc. / D-1172-2022

D-1172-2022 Class II Terminated

Recalled by Akorn, Inc. — Lake Forest, IL

Recall Details

Product Type
Drugs
Report Date
July 6, 2022
Initiation Date
June 13, 2022
Termination Date
July 14, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
44,400 bottles

Product Description

Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amber glass bottle, Rx only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC 50383-700-16

Reason for Recall

Defective container: defect prevents product from dispensing as intended.

Distribution Pattern

Nationwide USA

Code Information

Lot #: 379073, 379079, Exp 9/30/2023

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  • 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)