D-1555-2020 Class II Terminated
FDA drug recall D-1555-2020 was initiated by Laboratorios Jaloma S.A. de C.V. on July 31, 2020 and is designated Class II. Reason for recall: cGMP deviations The recall status is terminated (terminated August 23, 2022). Affected quantity: 211,875 bottles.
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