The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0951-2017·Announced 2017-07-12

Phillips Recalls StaphWash Skin Protectant Due to Manufacturing Deviations

Phillips Co. is recalling StaphWash+Plus+ Skin Protectant because FDA inspections found manufacturing practices that question the product's safety and quality.

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, which corresponds to a 'Severe' severity score under the rubric for significant manufacturing deviations affecting product safety and quality.

Plain-English summary

Phillips Co. is recalling StaphWash+Plus+ Skin Protectant, a zinc acetate solution in 0.3 fl. oz. bottles. The recall involves 10 to 30 units distributed nationwide and in the United Kingdom. All lots remaining within their expiration dates are affected.

The U.S. Food and Drug Administration (FDA) initiated this recall after an inspection identified significant Good Manufacturing Practice (GMP) deviations. These manufacturing practices call into question the safety, identity, strength, quality, and purity of the unexpired drug products manufactured by the firm.

Consumers should stop using the product and return it to the point of purchase or contact Phillips Co. for instructions on disposal or refund.

The recalled product

Product
StaphWash+Plus+ Skin Protectant, Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottle, Phillips Company, Millerton, OK -- NDC 43074-101-01
Manufacturer
Phillips Co.
Category
Drug — Topical Antiseptic
Hazard

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 remaining within expiry.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Phillips Co. 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 6 products in this recall →

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