Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor, FL 34684
Reported: February 20, 2019 Initiated: December 17, 2018 #D-0433-2019
Product Description
Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor, FL 34684
Reason for Recall
Lack of sterility assurance.
Details
- Recalling Firm
- Promise Pharmacy, LLC
- Units Affected
- 55 3 ml bottles
- Distribution
- Nationwide in the USA.
- Location
- Palm Harbor, FL
Frequently Asked Questions
What product was recalled? ▼
Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor, FL 34684. Recalled by Promise Pharmacy, LLC. Units affected: 55 3 ml bottles.
Why was this product recalled? ▼
Lack of sterility assurance.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 20, 2019. Severity: Moderate. Recall number: D-0433-2019.
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