Northwest Compounding Pharmacy Recalls Lidocaine Gel 1% Due to Sterility Concerns
Northwest Compounding Pharmacy is recalling Lidocaine gel 1% in Oregon due to a lack of sterility assurance. The product was distributed 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. Per 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 drug is a significant safety risk that aligns with the Severe classification for Class II recalls with potential for serious harm.
Plain-English summary
Hiers Enterprises, LLC dba Northwest Compounding Pharmacy is recalling Lidocaine gel 1%, a prescription compounded product packaged in a plastic dropper. The recall was initiated because the product lacks sterility assurance.
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 should stop using the recalled product and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- Lidocaine gel 1%, RX, plastic dropper
- 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)
- 10222018@40
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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