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

FDA recall notice · announced September 8, 2021 · Akorn

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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

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.

Notes

Distribution: Nationwide USA and Puerto Rico
Lot/code information: Lot #: 9G01A, Exp 06/2022; 9H32A, Exp 07/2022; 9K82A, 9K82B, Exp 09/2022
Quantity: 142,188 tubes
Status: Terminated
Products in this recall event:
- 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 (D-0786-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.