The Recall Desk
SevereFDA (Drugs)·D-0397-2019·Announced 2019-01-09

Northwest Compounding Pharmacy Recalls Lidocaine Gel Due to Sterility Concerns

Northwest Compounding Pharmacy is recalling Lidocaine gel 2% 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 infection from lack of sterility) are categorized as Severe.

Plain-English summary

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy is recalling Lidocaine gel 2%, RX, plastic dropper, 125 ml. The recall is due to a lack of sterility assurance in the product.

The affected product was distributed exclusively in the state of Oregon to 3 medical facilities, 1 physician's office, and 80 consumers/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 medical facilities should stop using the recalled product and contact their healthcare provider or the pharmacy for further instructions.

The recalled product

Product
Lidocaine gel 2%, RX, plastic dropper

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@15

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 →