The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0449-2016·Announced 2015-12-09

Western Drug Recalls Sal-Acid 60% Plaster Paste Due to Sterility Concerns

Western Drug is recalling Sal-Acid 60% Plaster Paste because the company cannot guarantee the product is sterile. The recall covers all lots distributed nationwide.

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 are assigned a severity score of 4 (Severe), particularly when involving significant risks such as lack of sterility assurance which can lead to infection.

Plain-English summary

Western Drug Inc. is voluntarily recalling Sal-Acid 60% Plaster Paste, a prescription product, because the company lacks assurance of the product's sterility. The recall includes all lots 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. The product is sold in 1-container quantities.

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

The recalled product

Product
Sal-Acid 60% Plaster Paste, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Manufacturer
Western Drug
Category
Drug — Topical Prescription
Hazard
Affected units
1

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 →

Related recalls

Same manufacturer · Western Drug

See all →

Same hazard · lack of sterility

See all →

Similar recalls