Acetylcysteine 2% Ophthalmic Solution Recalled for Sterility Concerns
Red Mountain Compounding Pharmacy is recalling Acetylcysteine 2% Ophthalmic Solution due to lack of assurance of sterility. The FDA identified concerns during an inspection of the manufacturing facility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a sterile pharmaceutical product (ophthalmic solution) where sterility assurance is critical for patient safety. Although no illnesses or injuries are reported in the source text, the hazard presents a significant risk of harm—sterile product defects can directly cause serious infection—and therefore meets the threshold for High severity per the rubric.
Plain-English summary
Red Mountain Compounding Pharmacy (First Royal Care Co. LLC) is recalling all lots of Acetylcysteine 2% Ophthalmic Solution (prescription only) due to lack of assurance of sterility.
During an FDA inspection, the agency identified concerns regarding the sterilization process and assurance of sterile conditions at the compounding facility. The product is intended for ophthalmic use, where sterility is critical to patient safety.
Approximately 494 patients and consumers who received prescriptions are located in Arizona, California, Florida, Minnesota, Montana, Texas, and Utah. All lots currently within their expiration dates are included in this recall.
Patients who have this medication should consult with their healthcare provider or pharmacist about whether they should discontinue use and obtain an alternative treatment. Healthcare providers and patients with questions may contact the recalling firm directly.
The recalled product
- Product
- ACETYLCYSTEINE 2% OPTH SOLN, Rx only, Red Mountain Compounding Rx
- Manufacturer
- First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Hazard
- lack-of-sterility
- compounding-defect
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
Distributed in 7 states:
- AZ
- CA
- FL
- MN
- MT
- TX
- UT
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