Modesa Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk
4e Brands North America is recalling Modesa hand sanitizer because it was manufactured in a facility associated with methanol contamination, representing poor manufacturing practices.
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 involves a product manufactured in a facility associated with methanol contamination, which is a significant injury risk.
Plain-English summary
4e Brands North America, Llc is recalling Modesa instant hand sanitizer with moisturizers & vitamin E (70% ethyl alcohol), 33.8 FL OZ (1 L) bottles. The recall involves 17,359,247 total bottles and pumps distributed nationwide in the USA. The product is distributed by Greenbrier International, Inc., and made in Mexico.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The product was manufactured in the same facility as a product found to contain methanol. This association represents poor manufacturing practices and poses a potential safety risk.
Consumers should stop using the recalled hand sanitizer immediately. The recall covers all lots within the expiry date. No specific lot numbers are provided in the source text, so consumers should check the product label for the UPC 0 32251 49935 7 to verify if their product is affected.
The recalled product
- Product
- Modesa instant HAND SANITIZER with moisturizers & vitamin E, (70% ethyl alcohol), 33.8 FL OZ (1 L) bottle, Distributed by Greenbrier International, Inc., 500 Volvo Parkway, Chesapeake, VA 23320, Made in Mexico. UPC 0 32251 49935 7
- Manufacturer
- 4e Brands North America, Llc
- Category
- Drug — Hand Sanitizer
- Hazard
- Affected units
- 17,359,247
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 (1)
- All lots within expiry
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by 4e Brands North America, Llc 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 10 products in this recall →Related recalls
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