Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Man...
FDA Drug Recall #D-0786-2021 — Class II — August 2, 2021
Recall Summary
| Recall Number | D-0786-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 2, 2021 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Akorn, Inc. |
| Location | Lake Forest, IL |
| Product Type | Drugs |
| Quantity | 142,188 tubes |
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
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.
Distribution Pattern
Nationwide USA and Puerto Rico
Lot / Code Information
Lot #: 9G01A, Exp 06/2022; 9H32A, Exp 07/2022; 9K82A, 9K82B, Exp 09/2022
Other Recalls from Akorn, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0818-2023 | Class II | Levofloxacin Injection 500mg/20 mL (25 mg/mL), ... | Apr 26, 2023 |
| D-0794-2023 | Class II | Clobetasol Propionate Cream, USP, 0.05%, packag... | Apr 26, 2023 |
| D-0790-2023 | Class II | Calcitriol Injection 1 mcg/mL, 1 mL ampules Rx ... | Apr 26, 2023 |
| D-0820-2023 | Class II | Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bo... | Apr 26, 2023 |
| D-0849-2023 | Class II | Timolol Maleate Ophthalmic Solution, USP 0.5%, ... | Apr 26, 2023 |
Frequently Asked Questions
Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.