Atropine Sulfate Ophthalmic Solution recall
Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. NDC: 17478-215-02
Why was Atropine Sulfate Ophthalmic Solution recalled?
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: 081031A, Exp 2/28/2023
- Product
- Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. NDC: 17478-215-02
- Recalling firm
- Akorn, Inc.
- Quantity
- 45,117 Bottles
- Distribution
- Nationwide in the USA and Puerto Rico
- Recall date
- February 15, 2023
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (drug)