Dermoplast Anesthetic Spray Recalled for Incorrect Net Weight Labeling
Advantice Health is recalling Dermoplast Anesthetic Spray canisters because some full cases contain cans labeled with an incorrect net weight of 2.75 oz instead of 2.0 oz.
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: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a minor labeling error regarding net weight, fitting the 'Low' severity criteria for cosmetic or documentation issues.
Plain-English summary
Advantice Health is recalling 111,492 canisters of Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY, 20%, 0.5%. The recall involves full cases of 12-2 oz. cans only, distributed nationwide in the USA by Moberg Pharma North America LLC. The specific product code is 80-6802, and the case UPC is 1 03 16864 68002 7.
The reason for the recall is a labeling error. Some full cases may contain canisters that incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz. The affected lot number is 14049A, with an expiration date of 12/21.
Consumers who have purchased this product should check their canisters for the incorrect net weight labeling. If the canisters are labeled as 2.75 oz, they should stop using the product and contact the recalling firm or distributor for further instructions.
The recalled product
- Product
- Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5%; full case of 12-2 oz. cans only; Distributed by Moberg Pharma North America LLC, Cedar Knolls, NJ 07927; Product Code 80-6802; Case UPC 1 03 16864 68002 7.
- Manufacturer
- Advantice Health
- Category
- Drug — Topical Anesthetic
- Hazard
- Affected units
- 111,492
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 #: 14049A
- Exp 12/21
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Advantice Health 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.
See all 2 products in this recall →Related recalls
Same manufacturer · Advantice Health
See all →- LowDermoplast Anesthetic Spray Recalled for Incorrect Net Weight Labeling
FDA (Drugs) · 2019-05-08
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