ASSURED Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk
4e Brands North America is recalling ASSURED Instant Hand Sanitizer due to manufacturing in a facility associated with methanol contamination, representing poor CGMPs.
What this means for you
Illness, injury, or structural failure has been reported. 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, a toxic substance that poses a significant health risk, meeting the criteria for a Severe rating.
Plain-English summary
4e Brands North America, LLC is recalling ASSURED Instant Hand Sanitizer Vitamin E and Aloe (70% ethyl alcohol). The product is packaged in 8 fL oz (236 ml) and 10 fL oz (296 ml) bottles, both with UPC 6 39277 49069 8. A total of 17,359,247 bottles and pumps were distributed nationwide in the USA. The product was made in Mexico and distributed by Geenbrier International, Inc.
The recall was initiated because the product was manufactured in the same facility as a product found to contain methanol. The FDA classifies this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers should stop using the recalled hand sanitizer and return it to the place of purchase for a refund or contact the recalling firm for instructions. The recall covers all lots within expiry.
The recalled product
- Product
- ASSURED Instant Hand Sanitizer Vitamin E and Aloe, (70% ethyl alcohol), Packaged as a) 8 fL oz / 236 ml bottle, UPC 6 39277 49069 8 b) 10 fL oz / 296 ml bottle, UPC 6 39277 49069 8, Distributed by Geenbrier International, Inc., 500 Volvo Parkway, Chesapeake, VA 23320, Made in Mex
- 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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