D-1555-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 9, 2020
- Initiation Date
- July 31, 2020
- Termination Date
- August 23, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 211,875 bottles
Product Description
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.
Reason for Recall
cGMP deviations
Distribution Pattern
Nationwide United States and Canada.
Code Information
Lot # a) 0005295, Exp 4/2022, 0006373, Exp 5/2022; b 0005412, Exp 4/2022, 0007134, Exp 5/2022, 0007834, Exp 5/2022, 0009239, Exp 6/2022