Northwest Compounding Pharmacy Recalls Cyclosporin Liquid Due to Sterility Concerns
Northwest Compounding Pharmacy is recalling Cyclosporin liquid 0.05% due to a lack of sterility assurance. The product was distributed in Oregon to medical facilities and patients.
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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or in this context, a critical sterility failure in a compounded drug, align with the Severe category (Score 4), as it exceeds the theoretical risk threshold of Score 3 due to the specific nature of the sterility defect in a medical product.
Plain-English summary
Hiers Enterprises, LLC dba Northwest Compounding Pharmacy is recalling Cyclosporin liquid 0.05%, a prescription compounded product packaged in plastic dropper bottles. The recall was initiated because the product lacks sterility assurance.
The affected product was distributed exclusively in the state of Oregon. Distribution included 3 medical facilities, 1 physician's office, and 80 consumers or patients. Because these are compounded products, labels vary for each specific patient, and the firm did not provide specific labeling details in the notice.
Patients who have received this product should contact their healthcare provider for instructions on how to proceed. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Cyclosporin liquid 0.05%, Rx, plastic dropper bottle
- Category
- Drug — Compounded Prescription
- 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)
- 10122018@30 11022018@18
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 17 recalled by Hiers Enterprises, LLC dba Northwest 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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