Promise Pharmacy Recalls Prednisolone and Gatifloxacin Eye Drops for Sterility Concerns
Promise Pharmacy is recalling 55 bottles of compounded Prednisolone and Gatifloxacin Ophthalmic Solution due to a lack of sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential hospitalization or significant injury risks associated with sterility failures in ophthalmic products.
Plain-English summary
Promise Pharmacy, LLC is recalling 55 3 mL bottles of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops. The product is a compounded prescription eye drop sold under the brand Promise Pharmacy. The recall was initiated because of a lack of sterility assurance.
The affected product is identified by Lot 11052018@4 with a beyond-use date of 1/18/2019. The recall is classified as FDA Class II. The distribution pattern is listed as nationwide in the USA.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- 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
- Manufacturer
- Promise Pharmacy, LLC
- Category
- Drug — Ophthalmic
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: 11052018@4 BUD: 1/18/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 51 recalled by Promise Pharmacy, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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