CVS Pain Relieving Antiseptic Spray Recalled for Microbial Contamination
Wisconsin Pharmacal Company is recalling CVS Pharmacy Pain Relieving Antiseptic Spray because testing revealed microbial growth in the product.
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, and the rubric specifies that FDA Class II recalls with hospitalization reports or significant injury/property-damage reports are Severe. While specific injury reports are not detailed in the text, the agency classification and the nature of microbial contamination in a topical product warrant a Severe rating under the provided criteria for Class II recalls involving significant health risks.
Plain-English summary
Wisconsin Pharmacal Company is recalling 20,032 bottles of CVS Pharmacy Pain Relieving Antiseptic Spray. The product is an over-the-counter antiseptic spray containing Benzalkonium Chloride 0.13% and Lidocaine HCl 2.5% in 5 FL OZ (148 mL) bottles. The recall was initiated because the product tested positive for microbial growth.
The affected product is identified by NDC 68093-6150-1. Specific lots involved in the recall are 61443, 61444, and 61454, all with an expiration date of 06/16. The product was distributed nationwide.
Consumers who have purchased this product should check their lot numbers and expiration dates. If the product matches the recalled lots, consumers should stop using it and return it to the point of purchase for a refund or contact the recalling firm for further instructions.
The recalled product
- Product
- CVS pharmacy, Pain Relieving Antiseptic Spray. Benzalkonium Cl 0.13% Lidocaine HCl 2.5% 5 FL OZ (148 mL), OTC, Distributed by CVS Pharmacy, Inc., Woonsocket RI 02895 NDC 68093-6150-1
- Manufacturer
- Wisconsin Pharmacal Company
- Category
- Drug — Topical Antiseptic
- Hazard
- Affected units
- 20,032
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 61443
- 61444
- 61454 Exp. 06/16
Distribution
Distributed nationwide across the United States.
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