Class II
Terminated
Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.
- Company
- Cipla
- Recall Initiated
- August 22, 2022
- Posted
- September 14, 2022
- Recall Number
- D-1499-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 117,844 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
Lot #: DEG1HC2, DEG2HC2, DEG3HC2, DEG4HC2, DEG5HC2, DEG6HC2, Exp 01/2023; DEG1IC2, DEG2IC2, DEG3IC2, DEG4IC2, Exp 02/2023; DEG1LC2, DEG2LC2, Exp 05/2023; DEG1BD2, DEG2BD2, DEG3BD2, Exp 07/2023
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