Why it was recalled
Lack of Assurance of Sterility
Product description
TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 30 Sterile Single-Use Vials per box, Akorn Consumer Health, A Division of Akorn, Inc., Ann Arbor, MI 48105. NDC 58790-010-30
Lot numbers, UPCs & expiration codes
Lot #: 913012, 913013, 913014, Exp. Date 1/31/2023
Where it was sold
Nationwide within theUSA
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-0717-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 8, 2021
- FDA report date
- Mar 30, 2022
- Quantity
- 62,331 box
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-0717-2022, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 89836
- Address
- 1925 W Field Ct Ste 300
- Code information
- Lot #: 913012, 913013, 913014, Exp. Date 1/31/2023
- Postal code
- 60045-4862
- Report date
- Mar 30, 2022
- Product type
- Drugs
- Recall number
- D-0717-2022
- Classification
- Class II
- Recalling firm
- Akorn, Inc.
- Product quantity
- 62,331 box
- Termination date
- Sep 28, 2023
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 30 Sterile Single-Use Vials per box, Akorn Consumer Health, A Division of Akorn, Inc., Ann Arbor, MI 48105. NDC 58790-010-30
- Distribution pattern
- Nationwide within theUSA
- Recall initiation date
- Sep 8, 2021
- Initial firm notification
- Letter
- Center classification date
- Mar 24, 2022