Prevantics Maxi Swabstick Recall Due to Manufacturing Validation Issues
Professional Disposables International is recalling Prevantics Maxi Swabstick (chlorhexidine gluconate and isopropyl alcohol) due to unvalidated test methods used during manufacturing. The company has not reported any illnesses or injuries.
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 manufacturing/validation issues (cGMP deviations) with no reported illnesses, injuries, or confirmed product defects. The hazard is procedural/compliance-based rather than direct patient harm, qualifying as a moderate precautionary recall.
Plain-English summary
Professional Disposables International, Inc. is recalling Prevantics Maxi Swabstick containing 3.15% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol. The recall affects two package configurations: individual pouches (NDC 10819-4076-4, 9,518 cases) and bulk cases of 300 swabsticks (NDC 10819-4076-3, 3,347 cases).
The recall is due to cGMP (current Good Manufacturing Practice) deviations. Specifically, the manufacturer identified uncertainty regarding the adequacy of validation for the test methods used to manufacture the products. This means the company cannot ensure that the analytical methods used during production reliably measure product quality and safety parameters.
The affected product was distributed nationwide in the USA and Puerto Rico. Multiple lot numbers are involved, with expiration dates ranging from February 2022 through May 2023. Consumers should stop using affected product and contact their healthcare provider or Professional Disposables International with questions. Prevantics Maxi Swabstick is a topical skin antiseptic preparation used prior to medical procedures.
The recalled product
- Product
- PREVANTICS MAXI SWABSTICK (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
- Brand
- PREVANTICS MAXI 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) 12000315
- Exp Feb 2022
- 12000700
- Exp Mar 2022
- 12001112 LE
- Exp Jun 2022
- 12001214
- Exp Jul 2022
- 12001362
- 12001406
- Exp Aug 2022
- 12001628
- Exp Sep 2022
- 12001856
- Exp Oct 2022
- 12002103
- Exp Dec 2022
- 12002113
- 12100024
- Exp Jan 2023
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.
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