Recalls / Class II
Class IID-0717-2022
Product
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
- Brand name
- Theratears Extra
- Generic name
- Carboxymethylcellulose Sodium, Unspecified
- Active ingredient
- Carboxymethylcellulose Sodium, Unspecified
- Route
- Ophthalmic
- NDC
- 58790-010
- FDA application
- M018
- Affected lot / code info
- Lot #: 913012, 913013, 913014, Exp. Date 1/31/2023
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Akorn, Inc.
- Manufacturer
- MEDTECH PRODUCTS INC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct Ste 300, N/A, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 62,331 box
- Distribution pattern
- Nationwide within theUSA
Timeline
- Recall initiated
- 2021-09-08
- FDA classified
- 2022-03-24
- Posted by FDA
- 2022-03-30
- Terminated
- 2023-09-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0717-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.