D-1498-2022 Class II Terminated
FDA drug recall D-1498-2022 was initiated by CIPLA on August 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 November 27, 2023). Affected quantity: 3,468 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- September 14, 2022
- Initiation Date
- August 22, 2022
- Termination Date
- November 27, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,468 bottles
Product Description
Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton, FL 33432, NDC 76282-708-50.
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 # DEG5BD2, Exp 07/2023