Northwest Compounding Pharmacy Recalls Cyclosporin Liquid Due to Sterility Concerns
Northwest Compounding Pharmacy is recalling compounded cyclosporin liquid 1% due to a lack of sterility assurance. The product was distributed in Oregon to medical facilities and patients.
What this means for you
Illness, injury, or structural failure has been reported. 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 with potential for significant injury or hospitalization (implied by lack of sterility assurance in a sterile product) are rated as Severe (4).
Plain-English summary
Hiers Enterprises, LLC dba Northwest Compounding Pharmacy is recalling compounded cyclosporin liquid 1% in plastic dropper bottles. The recall was initiated because the product lacks sterility assurance. This is a prescription medication that was distributed exclusively in the state of Oregon.
The affected product was distributed to three medical facilities, one physician's office, and 80 consumers or patients. Because these are compounded products, the labels vary for each compound and are specific to each patient. The firm did not provide specific labeling details in the recall notice.
Patients who have received this product should contact their healthcare provider for further instructions. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Cyclosporin liquid 1%, 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)
- 07192018@12
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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