AJR Trading Recalls Bio AAA Alcohol Gel Due to Methanol Presence
AJR Trading LLC is recalling 2,000 bottles of Bio AAA Alcohol Gel because methanol was found in other lots from the same facility.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk pathogen/contaminant (methanol) in a consumer product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
AJR Trading LLC is voluntarily recalling 2,000 bottles of Bio AAA Alcohol en Gel Antibacterial, 480 ml. The product is identified by Lot 20DF8307 and an expiration date of 04/2022. The gel was distributed in Florida.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Methanol was detected in other distributed lots of product manufactured in the same facility in Mexico. The source text does not report any illnesses or injuries associated with this specific lot.
Consumers who have this product should stop using it and contact AJR Trading LLC for a refund or further instructions.
The recalled product
- Product
- bio aaa Alcohol en Gel Antibacterial, Alcohol al 70% Cont. Neto 480 ml bottle, Hecho en Mexico por: AAA Cosmetica S.A. DE C.V. Recursos Hidraulicos No. 1 Secc. A, Col La Loma Zona Industrial, Tlalnepantla de Baz C.P. 54060 Edo. Mexico. UPC 7 502272 12108 5
- Manufacturer
- AJR TRADING LLC
- Category
- Drug — Topical Antiseptic
- Hazard
- Affected units
- 2,000
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)
- Lot: 20DF8307 Exp. 04/2022
Distribution
Distributed in 1 state:
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