D-1529-2019 Class III Terminated
FDA drug recall D-1529-2019 was initiated by NingBo Huize Commodity Co.,Ltd. on April 1, 2019 and is designated Class III. Reason for recall: CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. The recall status is terminated (terminated June 6, 2023). Affected quantity: 35,500.
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
- 35,500
Product Description
Accent Care of New York Home Care Nursing Personal Care Hand Sanitizer (Ethyl Alcohol 62%), 0.33 oz/10 mL, 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 #: 20170619, Exp 6/18/2019; 20170620, Exp 6/19/2019; 20170621, Exp 6/20/2019