Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot # DEG3LC2, Exp 05/2023
- 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:
- CIPLA
- Reason for Recall:
- Lack of Assurance of Sterility: Complaints received of defective container closure.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.
Product Codes/Lot Numbers:
Lot # DEG3LC2, Exp 05/2023
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1328-2022
Related Recalls
Lack of Assurance of Sterility: environmental monitoring failure.
Lack of Assurance of Sterility
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.