Drug product
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.
D-1555-2020
Product summary
- Event
- Event 86167
- Status
- Terminated
- Classification
- Class II
- Quantity
- 211,875 bottles
- Official record key
drug-enforcement:D-1555-2020
Official wording
Reason: cGMP deviations
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
Distribution pattern: Nationwide United States and Canada.
Derived failure modes
-
Manufacturing or process control
cGMP deviations