Recalls / Class II
Class IID-1499-2022
Product
Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, 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 #: DEG1HC2, DEG2HC2, DEG3HC2, DEG4HC2, DEG5HC2, DEG6HC2, Exp 01/2023; DEG1IC2, DEG2IC2, DEG3IC2, DEG4IC2, Exp 02/2023; DEG1LC2, DEG2LC2, Exp 05/2023; DEG1BD2, DEG2BD2, DEG3BD2, Exp 07/2023
Why it was recalled
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.
Recalling firm
- Firm
- CIPLA
- Manufacturer
- Cipla USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10 Independence Blvd, N/A, Warren, New Jersey 07059-2730
Distribution
- Quantity
- 117,844 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-08-22
- FDA classified
- 2022-09-07
- Posted by FDA
- 2022-09-14
- Terminated
- 2023-11-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1499-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.