Northwest Compounding Pharmacy Recalls Cyclosporin Liquid Due to Sterility Concerns
Northwest Compounding Pharmacy is recalling specific lots of compounded Cyclosporin liquid 2% for dry eye due to a lack of sterility assurance. The product was distributed in Oregon.
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 classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are rated Severe (4). While specific injury reports are not detailed in the snippet, the 'lack of sterility assurance' in a compounded injectable/ophthalmic product represents a significant risk of serious harm, aligning with the Severe criteria for Class II recalls with potential for significant injury.
Plain-English summary
Hiers Enterprises, LLC dba Northwest Compounding Pharmacy is recalling specific lots of Cyclosporin liquid 2%, a prescription compounded product used for dry eye. The recall is being conducted due to a lack of sterility assurance in the manufacturing process.
The affected product was distributed exclusively in the state of Oregon to three medical facilities, one physician's office, and 80 consumers or patients. The specific lots involved have expiration dates of February 13, 2019, and March 2, 2019, with manufacture dates in August, September, and October 2018.
Consumers and healthcare providers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Cyclosporin liquid 2%, Rx, plastic dropper bottle, dry eye
- 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 (3)
- 08172018@7 exp 2/13/19
- 09202018@16 exp 3/2/19
- 10172018@32 exp 3/2/19.
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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