Drug recall D-1499-2022
Product
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.
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
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
Recall details
- Recalling firm
- CIPLA, Warren, NJ
- Quantity
- 117,844 bottles
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 22, 2022
- Terminated
- November 27, 2023
Related products
- Difluprednate – drug information
- NDC 69097-341 Difluprednate · Difluprednate .5 mg/mL · Cipla USA Inc.