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.
Product description
Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton, FL 33432, NDC 76282-708-50.
Lot numbers, UPCs & expiration codes
Lot # DEG5BD2, Exp 07/2023
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-1498-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 22, 2022
- FDA report date
- Sep 14, 2022
- Quantity
- 3,468 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- CIPLA
Original FDA data
Every field from FDA enforcement report D-1498-2022, exactly as published.
Show all FDA fields
- City
- Warren
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 90796
- Address
- 10 Independence Blvd
- Code information
- Lot # DEG5BD2, Exp 07/2023
- Postal code
- 07059-2730
- Report date
- Sep 14, 2022
- Product type
- Drugs
- Recall number
- D-1498-2022
- Classification
- Class II
- Recalling firm
- CIPLA
- Product quantity
- 3,468 bottles
- Termination date
- Nov 27, 2023
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton, FL 33432, NDC 76282-708-50.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 22, 2022
- Initial firm notification
- Letter
- Center classification date
- Sep 7, 2022