The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0399-2016·Announced 2015-12-09

Western Drug Boric Acid Ear Drops Recalled for Sterility Concerns

Western Drug is recalling Boric Acid 1% Ear Drops due to a lack of assurance of sterility. The product was distributed nationwide in eight states.

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 the rubric specifies that FDA Class II recalls with potential for significant injury or hospitalization (implied by sterility failure in a medical product) fall under the Severe category.

Plain-English summary

Western Drug Inc. is recalling Boric Acid 1% Ear Drops, a prescription product, due to a lack of assurance of sterility. The recall involves 2 containers of the product.

The affected product was distributed nationwide in the United States, specifically in Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah. All lots of the product are included in this recall.

Consumers with this product should stop using it and contact their healthcare provider or pharmacist for instructions on how to dispose of the medication or obtain a replacement.

The recalled product

Product
Boric Acid 1% Ear Drop, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Manufacturer
Western Drug
Category
Drug — Ophthalmic/Ear Drops
Hazard
Affected units
2

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)

  • all lots

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Part of a larger recall action

This product is one of 91 recalled by Western Drug 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 91 products in this recall →

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