Home / Recalls / Akorn, Inc. / D-0802-2021

D-0802-2021 Class II Terminated

Recalled by Akorn, Inc. — Lake Forest, IL

Recall Details

Product Type
Drugs
Report Date
September 22, 2021
Initiation Date
August 13, 2021
Termination Date
August 17, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
264 bottles; 48 bottles lot 372286 and 216 bottles lot 372289

Product Description

Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL bottle (NDC 61748-480-30), b) 60 mL bottle (NDC 61748-480-60), Rx only, Manufactured by: Hi-Tech Pharmacal Co. Inc., Amityville,NY 11701

Reason for Recall

Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.

Distribution Pattern

USA Nationwide

Code Information

Lot #: a) 372286, 372289, Exp 1/31/2022, b) 372286, 372289, Exp 1/31/2022

Other recalls by Akorn, Inc.

  • D-0787-2023 Class II — Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, For I (April 26, 2023)
  • D-0856-2023 Class II — XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1.25mg/3mL, 0.5 mL u (April 26, 2023)
  • D-0790-2023 Class II — Calcitriol Injection 1 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Opera (April 26, 2023)
  • D-0858-2023 Class II — Calcitriol Injection 2 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Opera (April 26, 2023)
  • D-0817-2023 Class II — Levocarnitine Oral Solution, USP, 118 mL bottles, Rx Only, Distributed by: Akorn (April 26, 2023)
  • D-0788-2023 Class II — AK-POLY-BAC (bacitracin Zinc and Polymyxin B Sulfate) Ophthalmic Ointment, 3.5g, (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-0861-2023 Class II — Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 mL bottles, Rx Only, S (April 26, 2023)
  • D-0824-2023 Class II — Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes, Rx (April 26, 2023)
  • D-0845-2023 Class II — Sodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL, 15 mL bottles, Distribute (April 26, 2023)