Home / Recalls / Akorn, Inc. / D-0846-2022

D-0846-2022 Class III Terminated

Recalled by Akorn, Inc. — Lake Forest, IL

Recall Details

Product Type
Drugs
Report Date
May 11, 2022
Initiation Date
April 15, 2022
Termination Date
September 28, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
66,744 bottles

Product Description

Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, NDC 50383-775-04

Reason for Recall

Failed viscosity specification - product was below specificcation

Distribution Pattern

Nationwide USA and Puerto Rico

Code Information

Lot #: 370978, Exp 9/30/2022

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  • 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)
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