Recalls / Class II
Class IID-1328-2022
Product
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.
- Brand name
- Difluprednate
- Generic name
- Difluprednate
- Active ingredient
- Difluprednate
- Route
- Ophthalmic
- NDC
- 69097-341
- FDA application
- ANDA211776
- Affected lot / code info
- Lot # DEG3LC2, Exp 05/2023
Why it was recalled
Lack of Assurance of Sterility: Complaints received of defective container closure.
Recalling firm
- Firm
- CIPLA
- Manufacturer
- Cipla USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10 Independence Blvd, Warren, New Jersey 07059-2730
Distribution
- Quantity
- 7,992 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-08-02
- FDA classified
- 2022-08-05
- Posted by FDA
- 2022-08-17
- Terminated
- 2023-11-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1328-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.