Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL 600405, NDC 17478-622-35
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot#: 9J58A, 9J58B, Exp 8/31/2022
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Akorn, Inc.
- Reason for Recall:
- cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL 600405, NDC 17478-622-35
Product Codes/Lot Numbers:
Lot#: 9J58A, 9J58B, Exp 8/31/2022
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1496-2022
Related Recalls
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.