Home / Recalls / Akorn, Inc. / D-1046-2018

D-1046-2018 Class II Terminated

Recalled by Akorn, Inc. — Lake Forest, IL

Recall Details

Product Type
Drugs
Report Date
August 15, 2018
Initiation Date
August 1, 2018
Termination Date
November 6, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
22,605 tubes

Product Description

Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-667-30

Reason for Recall

Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12 months.

Distribution Pattern

Nationwide within the USA

Code Information

Lot #: 356309, Exp. 3/2019

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  • 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)