D-1499-2022 Class II Terminated
FDA drug recall D-1499-2022 was initiated by CIPLA on Aug 22, 2022 and is designated Class II. 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. The recall status is terminated (terminated Nov 27, 2023). Affected quantity: 117,844 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 14, 2022
- Initiation Date
- Aug 22, 2022
- Termination Date
- Nov 27, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 117,844 bottles
Product Description
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.
Distribution Pattern
Nationwide in the USA
Code Information
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1499-2022
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026