FDAClass IIIAugust 7, 2019

Texas Home Health Home Care Hospice Personal Care Hand recall: CGMP Deviations

Texas Home Health Home Care Hospice Personal Care Hand Sanitizer (Ethyl Alcohol 62%), 0.33 oz/10 mL, OTC, Made in China

Why was Texas Home Health Home Care Hospice Personal Care Hand recalled?

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 20180410, Exp 4/9/2020; 20180411, Exp 4/10/2020; 20180830, Exp 8/29/2020; 20180831, Exp 8/30/2020

Product
Texas Home Health Home Care Hospice Personal Care Hand Sanitizer (Ethyl Alcohol 62%), 0.33 oz/10 mL, OTC, Made in China
Recalling firm
NingBo Huize Commodity Co.,Ltd.
Quantity
50,000
Distribution
Foreign manufacturer located in China and distributed to seven consignees located in China.
Recall date
August 7, 2019
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls