Northwest Compounding Pharmacy Recalls Testosteron Cypionate Liquid Due to Sterility Concerns
Northwest Compounding Pharmacy is recalling Testosteron Cypionate liquid 200mg/ml because of 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 agency classified this as an FDA Class II recall. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe. While no specific injuries are reported in the text, the lack of sterility assurance in a compounded injectable product represents a significant risk of harm, aligning with the Severe classification for Class II recalls with potential for serious consequences.
Plain-English summary
Hiers Enterprises, LLC dba Northwest Compounding Pharmacy is recalling Testosteron Cypionate liquid 200mg/ml, a prescription product packaged in glass vials. The recall was initiated due to a lack of sterility assurance in the compounded product.
The affected product was distributed exclusively in 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, and the firm did not provide specific labeling details in the notice.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider for further instructions. The specific code information for the recalled product is 10012018@54 with an expiration date of 3/30/19.
The recalled product
- Product
- Testosteron Cypionate liquid 200mg/ml, RX, glass vial
- 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)
- 10012018@54 exp 3/30/19
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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