Dermoplast Anesthetic Spray Recalled for Incorrect Net Weight Labeling
Advantice Health is recalling Dermoplast Anesthetic Spray canisters because the label incorrectly states the net weight as 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, and the issue is a minor labeling error regarding net weight.
Plain-English summary
Advantice Health is recalling 111,492 canisters of Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY, 20%, 0.5%, Net WT 2.75 oz (78g). The product is distributed by Moberg Pharma North America LLC in Cedar Knolls, NJ, and was distributed nationwide in the USA. The specific lot number is 14049A with an expiration date of 12/21.
The recall was initiated due to a labeling error where the canisters incorrectly state the net weight is 2.75 oz rather than the correct net weight of 2.0 oz. This is classified as a labeling issue not elsewhere classified.
Consumers with this product should stop using it and contact the recalling firm for instructions on return or disposal. The FDA has classified this as a Class III recall, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5%, Net WT 2.75 oz (78g); Distributed by Moberg Pharma North America LLC, Cedar Knolls, NJ 07927; UPC 8 51409 00722 6
- 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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