Recalls / Class II
Class IID-1283-2022
Product
Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipla Ltd., India At M/S Indoco Remedies Limited., L-32, 33, 34, Verna Industrial area, Verna - Goa, 403722, India; Mfd. for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, 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
- Batch# DEG4LC2, exp. date 05/2023
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
- 8,136 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-07-14
- FDA classified
- 2022-07-20
- Posted by FDA
- 2022-07-27
- Terminated
- 2023-11-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1283-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.