Promise Pharmacy Recalls Prednisolone Ophthalmic Solution for Sterility Concerns
Promise Pharmacy is recalling compounded Prednisolone and Gatifloxacin and Bromfenac ophthalmic solution due to lack of sterility assurance. The recall covers 900 bottles distributed nationwide.
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 involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While specific injury reports are not detailed in the provided text, the agency classification and the nature of the defect (sterility in ophthalmic products) align with the Severe criteria for Class II recalls.
Plain-English summary
Promise Pharmacy, LLC is recalling 900 3 mL bottles of Prednisolone and Gatifloxacin and Bromfenac, Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops. The product is a compounded prescription eye drop sold under the brand Promise Pharmacy. The recall is being conducted due to a lack of sterility assurance.
The affected lots are 11012018@1 with a best-use date of 1/14/2019, and 11022018@1 with a best-use date of 1/15/2019. The product was distributed 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 and Bromfenac, Ophthalmic Solution, 1%/0.5%/0.09%, 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 (2)
- Lots: 11012018@1 BUD: 1/14/2019
- 11022018@1 BUD: 1/15/2019
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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