The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0404-2019·Announced 2019-01-09

Northwest Compounding Pharmacy Recalls Cyclosporin Liquid Due to Sterility Concerns

Northwest Compounding Pharmacy is recalling compounded Cyclosporin liquid 0.5% in plastic dropper bottles due to a lack of sterility assurance. The product was distributed in Oregon to medical facilities, a physician's office, 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, and the rubric specifies that FDA Class II recalls with potential for serious injury (such as lack of sterility assurance in a drug) map to a score of 4 (Severe).

Plain-English summary

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy is recalling Cyclosporin liquid 0.5%, a prescription compounded product packaged in plastic dropper bottles. The recall was initiated because the product lacks sterility assurance, which is a critical quality attribute for sterile pharmaceutical preparations.

The affected product was distributed exclusively within the state of Oregon. Distribution included three medical facilities, one physician's office, and 80 consumers or patients. Because these are compounded products, labels vary for each specific patient compound, and the firm did not provide specific labeling details in the recall notice.

Patients and healthcare providers who have received this product should stop using it and contact their healthcare provider or the pharmacy for further instructions on how to dispose of the medication or obtain a replacement.

The recalled product

Product
Cyclosporin liquid 0.5%, Rx, plastic dropper bottle
Manufacturer
Hiers Enterprises, LLC dba Northwest Compounding Pharmacy
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)

  • 07272018@2

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.

See all 17 products in this recall →

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