BonaDur For Men Lidocaine Spray Recalled for Manufacturing Deviations
Webrx dba RxPalace.com is recalling BonaDur For Men lidocaine spray because it was not manufactured according to current good manufacturing practices.
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 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 recall is classified as FDA Class III, which the rubric indicates is typically a score of 1 or 2. Given the CGMP deviation without specific reported harm, a score of 2 is appropriate.
Plain-English summary
Webrx dba RxPalace.com is recalling BonaDur For Men (lidocaine) spray, 10 mg per spray, 0.25 fl. oz. bottles. The product is identified by NDC 70582-999-74, Lot 17JXIII, and an expiration date of 12/31/2019.
The recall was initiated because the product was not manufactured according to current good manufacturing practices (CGMP). The source text does not specify the exact nature of the deviations or any reported illnesses or injuries.
The affected product was distributed in New York (NY). Consumers should stop using the product and contact the recalling firm for further instructions.
The recalled product
- Product
- BonaDur For Men (lidocaine) spray, 10 mg per spray, Net Contents .25 fl. oz. (7.4 mL) spray bottles, Manufactured by WebRx Pharmacy Palace, Sarasota, FL 34232; NDC 70582-999-74
- Manufacturer
- Webrx dba RxPalace.com
- Category
- Drug — Topical Anesthetic
- Hazard
- Affected units
- 1
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 (2)
- Lot: 17JXIII
- Exp. 12/31/2019
Distribution
Distributed in 1 state:
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