The Recall Desk
SevereFDA (Drugs)·D-0393-2019·Announced 2019-01-09

Northwest Compounding Pharmacy Recalls Epinephrine Liquid Due to Sterility Concerns

Northwest Compounding Pharmacy is recalling Epinephrine liquid 1:1000 in 50 ml glass vials 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe. While specific injury reports are not detailed in the provided text, the classification and the nature of the hazard (sterility in a compounded injectable) align with the Severe criteria for Class II recalls with potential for significant harm.

Plain-English summary

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy is recalling Epinephrine liquid 1:1000, prescription, in 50 ml glass vials. The recall was initiated because of a lack of sterility assurance in the product.

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. These are compounded products, meaning 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
Epinephrine liquid 1:1000, RX, glass vial

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 (2)

  • 10102018@13 exp 1/8/19
  • 10222018@33 exp 1/20/19

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.

See all 17 products in this recall →