Why it was recalled
Lack of Assurance of Sterility: Complaints received of defective container closure.
Product 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.
Lot numbers, UPCs & expiration codes
Lot # DEG3LC2, Exp 05/2023
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1328-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 2, 2022
- FDA report date
- Aug 17, 2022
- Quantity
- 7,992 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- CIPLA
Original FDA data
Every field from FDA enforcement report D-1328-2022, exactly as published.
Show all FDA fields
- City
- Warren
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 90702
- Address
- 10 Independence Blvd
- Code information
- Lot # DEG3LC2, Exp 05/2023
- Postal code
- 07059-2730
- Report date
- Aug 17, 2022
- Product type
- Drugs
- Recall number
- D-1328-2022
- Classification
- Class II
- Recalling firm
- CIPLA
- Product quantity
- 7,992 bottles
- Termination date
- Nov 27, 2023
- Reason for recall
- Lack of Assurance of Sterility: Complaints received of defective container closure.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 2, 2022
- Initial firm notification
- Letter
- Center classification date
- Aug 5, 2022