D-1564-2019 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 7, 2019
- Initiation Date
- April 1, 2019
- Termination Date
- June 6, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 126,500
Product Description
Lemon Hand Sanitizer (Alcohol 62%), 30 mL / 1.0 fl.oz, OTC, Made in China.
Reason for Recall
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Distribution Pattern
Foreign manufacturer located in China and distributed to seven consignees located in China.
Code Information
Lot #: 20170410, Exp 04/09/2019; 20170515, Exp 05/14/2019; 20170516, Exp 05/15/2019; 20170517, Exp 05/16/2019; 20170518, Exp 05/17/2019; 20170519, Exp 05/18/2019; 20170522, Exp 05/21/2019; 20170523, Exp 05/22/2019: 20170524, Exp 05/23/2019; 20170525, Exp 05/24/2019; 20170526, Exp 05/25/2019; 20180615, Exp 06/14/2020