D-0435-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 20, 2019
- Initiation Date
- December 17, 2018
- Termination Date
- March 30, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2057 6 ml bottles
Product Description
Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 6 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684
Reason for Recall
Lack of sterility assurance.
Distribution Pattern
Nationwide in the USA.
Code Information
Lots: 09192018@4 BUD: 12/18/2018; 10112018@1 BUD: 12/24/2018; 10262018@1 BUD: 1/8/2019; 10302018@1 BUD: 1/12/2019; 11082018@6 BUD: 1/21/2019