Recalls / Class II
Class IID-1498-2022
Product
Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton, FL 33432, NDC 76282-708-50.
- Affected lot / code info
- Lot # DEG5BD2, 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
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10 Independence Blvd, N/A, Warren, New Jersey 07059-2730
Distribution
- Quantity
- 3,468 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-1498-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.