Promise Pharmacy Recalls Acetylcysteine Ophthalmic Solution Due to Sterility Concerns
Promise Pharmacy, LLC is recalling 75 bottles of Acetylcysteine Ophthalmic Solution because the product lacks sterility assurance. The recall covers nationwide distribution in the USA.
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 agency classification is 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, fitting the 'Severe' criteria for significant injury reports or high-risk defects.
Plain-English summary
Promise Pharmacy, LLC is recalling 75 10 ml bottles of Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only. The product was manufactured by Promise Pharmacy Compounding Specialist in Palm Harbor, Florida.
The recall was initiated due to a lack of sterility assurance. The affected lot number is 11072018@10, with a beyond-use date of 12/22/2018. 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
- Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US Hwy 19N, Palm Harbor FL 34684.
- Manufacturer
- Promise Pharmacy, LLC
- Category
- Drug — Compounded 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: 11072018@10 BUD: 12/22/2018
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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