Northwest Compounding Pharmacy Recalls Hydroxyprogesterone Liquid Due to Sterility Concerns
Northwest Compounding Pharmacy is recalling Hydroxyprogesterone liquid, 250mg/ml, 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 serious injury (such as lack of sterility assurance in a compounded injectable) are classified as Severe.
Plain-English summary
Hiers Enterprises, LLC dba Northwest Compounding Pharmacy is recalling Hydroxyprogesterone liquid, 250mg/ml, in 20 ml glass vials. The recall is due to a lack of sterility assurance. The product is a prescription compounded medication.
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 compound and are specific to each patient. The firm did not provide specific labeling details.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- Hydroxyprogesterone liquid, 250mg/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)
- 10252018@24
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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