FDAFDA · Food and drugs·Recall number D-1328-2022
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.
Published August 17, 2022 · Recall initiated: August 2, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: Complaints received of defective container closure.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DIFLUPREDNATE
- Manufacturer
- CIPLA
- Distributor
- Nationwide in the USA
- Lot
- Lot # DEG3LC2, Exp 05/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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