Jaloma Antiseptic Hand Sanitizer

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

cGMP deviations

Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.

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.

Affected NDCs 65055-0600-01 65055-0600-02

Compare with the code on your package — it is the most precise check available.

Drug: Alcohol

Recalling firm: Laboratorios Jaloma S.A. de C.V.
NDC code: 65055-600-02
Origin: N/A, Mexico
Initiated by: Voluntary: Firm initiated
Company announcement: Jul 31, 2020 · FDA notice with lot numbers
FDA recall number: D-1555-2020 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.