Why it was recalled
Failed Stability Specification: OOS low viscosity results discovered during retain testing.
Product description
Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-215-05
Lot numbers, UPCs & expiration codes
Lot: 011037A
Where it was sold
Nationwide in the USA
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-0577-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 21, 2018
- FDA report date
- Mar 14, 2018
- Quantity
- 31,812 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-0577-2018, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 79278
- Address
- 1925 W Field Ct Ste 300
- Code information
- Lot: 011037A
- Postal code
- 60045-4862
- Report date
- Mar 14, 2018
- Product type
- Drugs
- Recall number
- D-0577-2018
- Classification
- Class III
- Recalling firm
- Akorn, Inc.
- Product quantity
- 31,812 bottles
- Termination date
- Aug 31, 2020
- Reason for recall
- Failed Stability Specification: OOS low viscosity results discovered during retain testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-215-05
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Feb 21, 2018
- Initial firm notification
- Letter
- Center classification date
- Mar 5, 2018