FDA-Drug2023-06-07Class II

Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Akorn, Inc.
Hazard

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Sold states
Nationwide in the USA and Puerto Rico
Affected count
N/A
Manufactured in
5605 Centerpoint Ct Ste A, N/A, Gurnee, IL, United States
Products
Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0835-2023

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