The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0456-2016·Announced 2015-12-09

Western Drug Recalls Tacrolimus Eye Drops Due to Sterility Concerns

Western Drug is recalling two containers of Tacrolimus 0.02% Opth Sol 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. According to the rubric, FDA Class II recalls with potential for significant injury or hospitalization (implied by sterility failure in an ophthalmic product) are rated as Severe (4).

Plain-English summary

Western Drug Inc. is recalling two containers of Tacrolimus 0.02% Opth Sol, a prescription eye solution. The recall was initiated because the product lacks assurance of sterility. This means the manufacturer cannot guarantee that the eye drops are free from microbial contamination.

The affected product is distributed nationwide in the United States, specifically in Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah. The recall covers all lots of the product.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
Tacrolimus 0.02% Opth Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Manufacturer
Western Drug
Category
Drug — Ophthalmic Solution
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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