Why it was recalled
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Product description
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
Lot numbers, UPCs & expiration codes
Lot: 081031A, Exp 2/28/2023
Where it was sold
Nationwide in the USA and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0265-2023
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Jan 30, 2023
- FDA report date
- Feb 15, 2023
- Quantity
- 45,117 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-0265-2023, exactly as published.
Show all FDA fields
- City
- Gurnee
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 91580
- Address
- 5605 Centerpoint Ct Ste A
- Code information
- Lot: 081031A, Exp 2/28/2023
- Postal code
- 60031-5278
- Report date
- Feb 15, 2023
- Product type
- Drugs
- Recall number
- D-0265-2023
- Classification
- Class III
- Recalling firm
- Akorn, Inc.
- Product quantity
- 45,117 Bottles
- Reason for recall
- Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Jan 30, 2023
- Initial firm notification
- Letter
- Center classification date
- Feb 8, 2023