Acetylcysteine 10% ophthalmic solution recalled for sterility assurance concerns
Red Mountain Compounding Pharmacy is recalling Acetylcysteine 10% ophthalmic solution due to lack of sterility assurance identified during an FDA inspection. Approximately 494 patients received prescriptions for the product across seven states.
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 product is classified as FDA Class II and involves a sterile compounded ophthalmic preparation. Lack of sterility assurance in eye drops poses a significant risk of infection, warranting a Severe classification per the rubric.
Plain-English summary
Red Mountain Compounding Pharmacy, operating as First Royal Care Co. LLC, is recalling Acetylcysteine 10% ophthalmic solution (eye drops). The FDA identified sterility assurance concerns during an inspection of the compounding facility.
The recalled product was distributed to approximately 494 patients who received prescriptions. Distribution occurred across Arizona, California, Florida, Minnesota, Montana, Texas, and Utah. All affected lots were within their expiration dates at the time of the recall.
Patients who have received this product should contact their healthcare provider or pharmacist for guidance. Healthcare providers should advise patients to discontinue use and obtain an alternative medication if appropriate.
The recalled product
- Product
- ACETYLCYSTEINE 10% OPTH SOLN, Red Mountain Compounding Rx
- Category
- Drug — Compounded ophthalmic
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)
- all lots within expiry
Distribution
Part of a larger recall action
This product is one of 40 recalled by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy 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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