Class II
Terminated
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.
- Company
- Cipla
- Recall Initiated
- July 14, 2022
- Posted
- July 27, 2022
- Recall Number
- D-1283-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 8,136 bottles
- Firm Location
- Warren, NJ, United States
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
Nationwide in the USA
Lot / Code Info
Batch# DEG4LC2, exp. date 05/2023
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