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LABORATORIOS JALOMA S.A. de C.V. Issues Voluntary Recall of the Jaloma Antiseptic Hand Sanitizer Due to the Potential Presence of Undeclared Methanol

August 1, 2020 from the FDA

LABORATORIOS JALOMA S.A. de C.V. is voluntarily recalling all lots and all bottle sizes of the Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% With vitamin E to the consumer level. This recall has been initiated because FDA sampled the 500 mL product and found it to be contaminated with undeclared methanol (wood alcohol). Although the contamination was linked to the 500 mL product, due to the abundance of caution, Jaloma is recalling all lots of all sizes within expiry. The NDCs, lot #s, and expiration dates are listed in the table below.

The product is used as a hand sanitizer for hand washing to decrease bacteria on the skin when soap and water are not available. The products are distributed in a 4 fl oz (120 mL) Polyethylene Terephthalate (PET) plastic bottle and a 16.9 fl oz (1.06 pt) (500 mL) PET or High-density polyethylene (HDPE) plastic bottle. Product is labeled with a red logo with the word Jaloma written in white letters. The product was distributed throughout the United States. It was imported to one (1) wholesaler and two (2) distributors.

Each product contains a lot number and expiration date stamped directly on the bottle or on the label of the 16.9 fl oz HDPE bottle in the format below. See table for lot numbers of each individual bottle.

• 0007834
• EXP0522

Consumers with questions regarding this recall can contact LABORATORIOS JALOMA S.A. de C.V. during business hours: 9:00am – 5:00pm (CT) Toll Free: + 52 1 800 120 0202 Email: asuntosregulatorios@jaloma.com.mx