STATES:  Nationwide
RECALL:   LABORATORIOS JALOMA S.A. de C.V.  recalling all lots and all bottle sizes of the Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% With vitamin E. 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 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.
 

Risk Statement: Substantial methanol exposure could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, and permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning. To date, LABORATORIOS JALOMA S.A. de C.V. has not received any reports of adverse events related to this recall.  

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.  (EXAMPLE:  0007834   Exp 0522)

RECALLED PRODUCTS

Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% With vitamin E

NDCs 65055-600-02,   SIZE:    16.9 fl oz. (1.06 pt) (500 mL)   UPC 7 59684 51503 3
LOT #s & EXPIRATION DATES0005295  Exp: April 2022;  0006373 Exp: May 2022

Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% With vitamin E

NDCs 65055-600-01,    SIZE:  4 fl oz (120 mL)  UPC 7 59684 51502 6

LOT #s & EXPIRATION DATES0005412 Exp: April 2022;  0007134  Exp: May 2022;
0007834  Exp: May 2022;  0009239  Exp: June 2022

ACTION:  Stop using; return it to the place of purchase.  LABORATORIOS JALOMA S.A. de C.V.is arranging for return and refund of all recalled products.  Contact your physician or healthcare provider if experiencing any problems that may be related to taking or using this product.

CONTACT:  LABORATORIOS JALOMA S.A. de C.V. during business hours: 9:00 am – 5:00 pm (CT) Toll-Free: + 52 1 800 120 0202. Email: asuntosregulatorios@jaloma.com.mx

Source:  FDA

1-386-428-0300              New Smyrna Beach, Florida

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