D-1283-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 27, 2022
- Initiation Date
- July 14, 2022
- Termination Date
- November 27, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,136 bottles
Product Description
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.
Distribution Pattern
Nationwide in the USA
Code Information
Batch# DEG4LC2, exp. date 05/2023