The Recall Desk
ModerateFDA (Drugs)·D-0421-2018·Announced 2018-02-21

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.

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: 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:

Related recalls

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