D-1498-2022 Class II Terminated
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