The Recall Desk
ModerateFDA (Drugs)·D-0571-2022·Announced 2022-03-02

Prevantics Swab Drug Recall for Test Method Validation Deficiency

Professional Disposables International, Inc. is recalling Prevantics Swab (chlorhexidine gluconate and isopropyl alcohol) due to cGMP deviations involving inadequate validation of manufacturing test methods. The product was distributed nationwide in the USA and Puerto Rico.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall involving cGMP deviations related to test method validation—a manufacturing process deficiency rather than a direct safety hazard with reported illness or injury. The source text does not report any illnesses, injuries, or confirmed product failures, making this a precautionary recall grounded in manufacturing compliance concerns.

Plain-English summary

Professional Disposables International, Inc. is recalling Prevantics Swab, which contains chlorhexidine gluconate (3.15% w/v) and isopropyl alcohol (70% v/v). The recall affects two packaged configurations: individual 1 mL swabs in pouches (100 per carton or 3000 per case), distributed with specific lot numbers and expiration dates ranging from February 2022 through May 2023.

The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations. Specifically, the FDA determined there was uncertainty regarding the adequacy of validation of the test methods used to manufacture the products.

The affected product was distributed nationwide in the United States and Puerto Rico. A total of 160,531 cases of the 100-swab configuration and 16,123 cases of the 3,000-swab configuration are subject to this recall.

Consumers and healthcare facilities in possession of affected lots should stop using the product and contact Professional Disposables International, Inc. for instructions on return or disposal.

The recalled product

Product
PREVANTICS SWAB (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
Brand
PREVANTICS SWAB
Manufacturer
Professional Disposables International, Inc.
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 (20)

  • Lot #: a) 12000165
  • 12000166
  • 12000382
  • Exp Feb 2022
  • 12000228
  • 12000381
  • 12000383
  • 12000577
  • 12000578
  • 12000579
  • 12000661
  • 12000662
  • Exp Mar 2022
  • 12000659
  • 12000660
  • Exp Apr 2022
  • 12001060
  • 12001061
  • 12001062
  • 12001100 LE

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by Professional Disposables International, Inc. 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 3 products in this recall →

Related recalls

Same manufacturer · Professional Disposables International, Inc.

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Same hazard · cGMP deviation

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