Promise Pharmacy Recalls Prednisolone and Gatifloxacin Ophthalmic Solution Due to Precipitate
Promise Pharmacy LLC is recalling Prednisolone and Gatifloxacin Ophthalmic Solution due to the presence of precipitate. The recall covers nationwide distribution.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classified this as an FDA Class III recall, which is defined as unlikely to cause adverse health consequences. The hazard is a physical defect (precipitate) without reported injuries.
Plain-English summary
Promise Pharmacy LLC is recalling Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only. The recall was initiated due to the presence of precipitate in the product.
The affected product is identified by Lot # 04092018@2 with an expiration date of 12/03/2018. The recall covers distribution across the United States nationwide.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for further instructions.
The recalled product
- Product
- Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 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)
- Lot#: 04092018@2
- Exp 12/03/2018
Distribution
Distributed nationwide across the United States.
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