Home / Recalls / Akorn, Inc. / D-1883-2019

D-1883-2019 Class II Terminated

Recalled by Akorn, Inc. — Lake Forest, IL

Recall Details

Product Type
Drugs
Report Date
October 9, 2019
Initiation Date
September 20, 2019
Termination Date
August 1, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
60,176 bottles

Product Description

Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15.

Reason for Recall

Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.

Distribution Pattern

Nationwide in the USA and Puerto Rico

Code Information

Lot #: 031908A, Exp 03/20

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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)
  • D-0854-2023 Class II — Valproic Acid Oral Solution, USP, 250mg/5mL, 473 mL bottles, Rx only, Distribu (April 26, 2023)