Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL bottles, and C) 15 mL bottles, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Reported: June 7, 2023 Initiated: April 26, 2023 #D-0779-2023
Product Description
Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL bottles, and C) 15 mL bottles, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Reason for Recall
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Details
- Recalling Firm
- Akorn, Inc.
- Units Affected
- N/A
- Distribution
- Nationwide in the USA and Puerto Rico
- Location
- Gurnee, IL
Frequently Asked Questions
What product was recalled? ▼
Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL bottles, and C) 15 mL bottles, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs. Recalled by Akorn, Inc.. Units affected: N/A.
Why was this product recalled? ▼
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 7, 2023. Severity: Moderate. Recall number: D-0779-2023.
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