Why it was recalled
Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stability testing. The microbiological investigation identified the organism as a member of the Bacillus cereus group.
Product description
Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-062-35
Lot numbers, UPCs & expiration codes
Lot #: 9G01A, Exp 06/2022; 9H32A, Exp 07/2022; 9K82A, 9K82B, Exp 09/2022
Where it was sold
Nationwide 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-0786-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 2, 2021
- FDA report date
- Sep 8, 2021
- Quantity
- 142,188 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-0786-2021, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 88594
- Address
- 1925 W Field Ct Ste 300
- Code information
- Lot #: 9G01A, Exp 06/2022; 9H32A, Exp 07/2022; 9K82A, 9K82B, Exp 09/2022
- Postal code
- 60045-4862
- Report date
- Sep 8, 2021
- Product type
- Drugs
- Recall number
- D-0786-2021
- Classification
- Class II
- Recalling firm
- Akorn, Inc.
- Product quantity
- 142,188 tubes
- Termination date
- Aug 22, 2022
- Reason for recall
- Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stability testing. The microbiological investigation identified the organism as a member of the Bacillus cereus group.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-062-35
- Distribution pattern
- Nationwide USA and Puerto Rico
- Recall initiation date
- Aug 2, 2021
- Initial firm notification
- Letter
- Center classification date
- Aug 31, 2021