Promise Pharmacy Recalls Prednisolone and Gatifloxacin Ophthalmic Solution for Sterility Concerns
Promise Pharmacy is recalling 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, and the hazard involves a lack of sterility assurance in an ophthalmic product, which poses a significant risk of serious injury or adverse health consequences.
Plain-English summary
Promise Pharmacy, LLC is recalling 250 bottles of Prednisolone and Gatifloxacin and Ketorolac Ophthalmic Solution 1%/0.5%/0.5%, Combo Drops: 3 mL. The recall was initiated because of a lack of sterility assurance in the product.
The affected product is a compounded prescription ophthalmic solution distributed nationwide in the USA. The specific lots involved are 09262018@5 with a best use date of 1/15/2019, 10092018@1 with a best use date of 1/25/2019, and 11052018@1 with a best use date of 2/21/2019.
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 Gatifloxacin and Ketorolac Ophthalmic Solution 1%/0.5%/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 Solution
- 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 (3)
- Lots: 09262018@5 BUD: 1/15/2019
- 10092018@1 BUD: 1/25/2019
- 11052018@1 BUD: 2/21/2019
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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