The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0455-2016·Announced 2015-12-09

Western Drug Recalls T.C.A 30% Acid Solution Due to Sterility Concerns

Western Drug is recalling T.C.A 30% Acid Solution because the product lacks assurance of sterility. The recall affects one container 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterility issue) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for theoretical risk or unreported injury.

Plain-English summary

Western Drug is recalling one container of T.C.A 30% Acid Solution, a prescription product. The recall was initiated because the product lacks assurance of sterility.

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 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.

The recalled product

Product
T.C.A 30% Acid Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Manufacturer
Western Drug
Category
Drug — Topical Solution
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 →

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