Promise Pharmacy Recalls Prednisolone Ophthalmic Solution Due to Sterility Concerns
Promise Pharmacy is recalling compounded Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution due to a lack of sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 infection.
Plain-English summary
Promise Pharmacy, LLC is recalling 2,057 bottles of Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 6 mL. The product is a compounded prescription ophthalmic solution distributed nationwide in the USA.
The recall was initiated due to a lack of sterility assurance. The affected lots include 09192018@4, 10112018@1, 10262018@1, 10302018@1, and 11082018@6, with best-use dates ranging from December 18, 2018, to January 21, 2019.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 6 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 (5)
- Lots: 09192018@4 BUD: 12/18/2018
- 10112018@1 BUD: 12/24/2018
- 10262018@1 BUD: 1/8/2019
- 10302018@1 BUD: 1/12/2019
- 11082018@6 BUD: 1/21/2019
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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