CVS Lidocaine Wound Gel recalled for failed pH specifications
CVS Lidocaine Wound Gel is being recalled because it failed pH specifications. The affected product is distributed nationwide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall, which by definition is unlikely to cause adverse health consequences. No illnesses or injuries have been reported, and the hazard is a specification defect rather than a direct safety threat.
Plain-English summary
Water-Jel Technologies, LLC is recalling CVS Lidocaine Wound Gel (Benzalkonium Chloride 0.13% and Lidocaine Hydrochloride 2%) distributed nationwide. The product, supplied in 0.5 oz (14 g) tubes under NDC 59898-950, is being recalled due to failed pH specifications.
Affected lot numbers are A5014, A5018, and A5019. Consumers who have purchased this product should stop using it and consult their healthcare provider or pharmacist if they have questions about whether the product is safe for their use.
This is a Class III recall. No adverse events have been reported to date.
The recalled product
- Product
- Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2%), NET WT 0.5 OZ (14 g), Distributed by: CVS PHarmacy, INc., One CVS Drive, Woonsocket, RI 02895. NDC 59898-950
- Manufacturer
- Water-Jel Technologies, LLC
- Category
- Drug — Topical Anesthetic
- Hazard
- Affected units
- 31,488
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 (3)
- Lots: A5014
- A5018
- A5019
Distribution
Distributed nationwide across the United States.
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