Promise Pharmacy Recalls Prednisolone and Moxifloxacin Eye Drops for Sterility Concerns
Promise Pharmacy is recalling 43 bottles of compounded Prednisolone and Moxifloxacin 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, which corresponds to a Severe rating under the rubric, particularly given the risk of infection associated with non-sterile ophthalmic products.
Plain-English summary
Promise Pharmacy, LLC is recalling 43 3 mL bottles of Prednisolone and Moxifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops. The recall is being conducted because of a lack of sterility assurance for the product.
The affected product is a compounded prescription eye drop identified by Lot 10252018@8 with a beyond-use date of 2/10/2019. The recall covers distribution nationwide in the USA.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- Prednisolone and Moxifloxacin 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: 10252018@8 BUD: 2/10/2019
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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