Prevantics Swabstick Chlorhexidine Recall Due to Test Validation Uncertainty
Professional Disposables International is recalling Prevantics Swabstick (chlorhexidine gluconate and isopropyl alcohol) products nationwide due to uncertain validation of the test methods used during manufacturing.
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 2/5 (Moderate).
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: The FDA classified this as Class II. The recall is based on manufacturing process validation deficiencies (cGMP deviations) rather than confirmed product defects or reported harm. No illnesses or injuries are documented in the source, and the hazard is process-related and precautionary rather than direct contamination or safety failure.
Plain-English summary
Professional Disposables International, Inc. is recalling Prevantics Swabstick containing chlorhexidine gluconate 3.15% w/v and isopropyl alcohol 70% v/v. The recall affects three packaging configurations with lot numbers ranging from 12000203 through 12100817, with expiration dates from February 2022 through June 2023. The product was distributed nationwide in the USA and Puerto Rico.
The FDA classified this as a Class II recall due to current good manufacturing practice (cGMP) deviations. Specifically, the manufacturer identified uncertainty regarding the adequacy of validation of the test methods used to manufacture the products.
Consumers and healthcare providers who have these products should discontinue use. Healthcare facilities should quarantine affected product and consult their recall notification for instructions on return or destruction. No illnesses or injuries have been reported to date.
The recalled product
- Product
- PREVANTICS SWABSTICK (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
- Brand
- PREVANTICS SWABSTICK
- Manufacturer
- Professional Disposables International, Inc.
- Category
- Drug — Topical Antiseptic
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) 12000203
- 12000204
- Exp Mar 2022
- 12001114 LE
- Exp Jun 2022
- 12001115 LE
- 12001117 LE
- Exp Jul 2022
- 12001313
- 12001407
- 12001408
- Exp Aug 2022
- 12001498
- 12001499
- 12001500
- 12001629
- 12001630
- Exp Sep 2022
- 12002070
- 12002114
Distribution
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
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