Drug & medication recalls Moderate risk

Jaloma Antiseptic Hand Sanitizer recalled over manufacturing violations

Recall date
July 31, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Laboratorios Jaloma S.A. de C.V. recalls Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% with Vitamin E, packaged in a) 16.9 Fl. Oz. (1.06 pint, 500 mL), ND…
Recall number
D-1555-2020
FDA classification
Class II
Brand / firm
Laboratorios Jaloma S.A. de C.V.
Sold / distributed
Nationwide United States and Canada.

Why it was recalled

cGMP deviations

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% with Vitamin E, packaged in a) 16.9 Fl. Oz. (1.06 pint, 500 mL), NDC# 65055-600-02, UPC# 759684515033, b) 4 Fl. Oz.(120 mL), NDC# 65055-600-01, UPC# 75968455026, Laboratorios Jaloma S.A. DE C.V., Aquiles Serdan 438, Z.P. 44380, Guadalajara, Jalisco, Mexico, Made in Mexico.

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