Drug recall D-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.
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.
Lots and codes
Batch# DEG4LC2, exp. date 05/2023
Recall details
- Recalling firm
- CIPLA, Warren, NJ
- Quantity
- 8,136 bottles
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 14, 2022
- Terminated
- November 27, 2023
Related products
- Difluprednate – drug information
- NDC 69097-341 Difluprednate · Difluprednate .5 mg/mL · Cipla USA Inc.