Northwest Compounding Pharmacy Recalls Lidocaine/Epinephrine Liquid Due to Sterility Concerns
Northwest Compounding Pharmacy is recalling Lidocaine/Epinephrine liquid 1%/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.
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 involves a lack of sterility assurance in an injectable medication, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
Hiers Enterprises, LLC dba Northwest Compounding Pharmacy is recalling Lidocaine/Epinephrine liquid 1%/1:1000, prescription (RX), in 50 ml glass vials. The recall is being conducted due to a lack of sterility assurance in the compounded 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. Because these are compounded products, labels vary for each specific patient, and the firm did not provide specific labeling details.
Consumers and healthcare providers who have received this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Lidocaine/Epinepherine liquid 1%/ 1:1000, RX, glass vial These include injectable medications, sterile solutions, eye drops, and eye ointments
- Category
- Drug — Compounded Injectable
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)
- 08072018@30
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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