Multi-event April 2019 FDA Recall Drug by Ningbo Huize Commodity Co.,ltd.
This Multi-event Class III drug recall was voluntarily initiated by Ningbo Huize Commodity Co.,ltd. on April 1, 2019 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Foreign manufacturer located in China and distributed to seven consignees located in China. and the recall is currently terminated.
Reported Recall Events
D-1563-2019 D-1558-2019 D-1564-2019 D-1535-2019 D-1551-2019 D-1560-2019 D-1539-2019 D-1562-2019 D-1561-2019 D-1532-2019 D-1547-2019 D-1529-2019 D-1553-2019 D-1557-2019 D-1550-2019 D-1559-2019 D-1549-2019 D-1542-2019 D-1556-2019 D-1545-2019 D-1544-2019 D-1555-2019 D-1552-2019 D-1530-2019 D-1531-2019 D-1537-2019 D-1554-2019 D-1546-2019 D-1534-2019 D-1540-2019 D-1533-2019 D-1543-2019 D-1548-2019 D-1536-2019 D-1541-2019 D-1538-2019
Recall Number: D-1563-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
04-01-2019
08-07-2019
13,068
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NingBo Huize Commodity Co.,Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Foreign manufacturer located in China and distributed to seven consignees located in China.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
DIPPIN' DOTS SCENTED COTTON CANDY ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Batch or Lot Expiration Information
Lot# : 20181213, Exp 12/12/2020
Recall Number: D-1558-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
04-01-2019
08-07-2019
13,068
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NingBo Huize Commodity Co.,Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Foreign manufacturer located in China and distributed to seven consignees located in China.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
ICEE CHERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Batch or Lot Expiration Information
Lot# : 20181204, Exp 12/3/2020; 20181205, Exp 12/4/2020
Recall Number: D-1564-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
04-01-2019
08-07-2019
126,500
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NingBo Huize Commodity Co.,Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Foreign manufacturer located in China and distributed to seven consignees located in China.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Lemon Hand Sanitizer (Alcohol 62%), 30 mL / 1.0 fl.oz, OTC, Made in China.
Batch or Lot Expiration 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
Recall Number: D-1535-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
04-01-2019
08-07-2019
5112
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NingBo Huize Commodity Co.,Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Foreign manufacturer located in China and distributed to seven consignees located in China.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Tootsie Roll POP ORANGE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Batch or Lot Expiration Information
Lot# : 20181015, Exp 10/14/2020
Recall Number: D-1551-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
04-01-2019
08-07-2019
8,856
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NingBo Huize Commodity Co.,Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Foreign manufacturer located in China and distributed to seven consignees located in China.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
TOOTSIE ROLL SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Batch or Lot Expiration Information
Lot# : 20181115, Exp 11/14/2020
Recall Number: D-1560-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
04-01-2019
08-07-2019
13,068
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NingBo Huize Commodity Co.,Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Foreign manufacturer located in China and distributed to seven consignees located in China.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
DIPPIN' DOTS SCENTED BANANA SPLIT ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Batch or Lot Expiration Information
Lot# : 20181210, Exp 12/09/2020
Recall Number: D-1539-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
04-01-2019
08-07-2019
3852
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NingBo Huize Commodity Co.,Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Foreign manufacturer located in China and distributed to seven consignees located in China.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
DOTS SCENTED ANTIBACTERIAL HAND GEL LIME (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Batch or Lot Expiration Information
Lot# : 20181022, Exp 10/21/2020
Recall Number: D-1562-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
04-01-2019
08-07-2019
13,068
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NingBo Huize Commodity Co.,Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Foreign manufacturer located in China and distributed to seven consignees located in China.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
DIPPIN' DOTS SCENTED COOKIES 'N CREAM ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Batch or Lot Expiration Information
Lot# : 20181212, Exp 12/11/2020
Recall Number: D-1561-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
04-01-2019
08-07-2019
13,068
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NingBo Huize Commodity Co.,Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Foreign manufacturer located in China and distributed to seven consignees located in China.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
DIPPIN' DOTS SCENTED BIRTHDAY CAKE ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Batch or Lot Expiration Information
Lot# : 20181211, Exp 12/10/2020
Recall Number: D-1532-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
04-01-2019
08-07-2019
10, 000
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NingBo Huize Commodity Co.,Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Foreign manufacturer located in China and distributed to seven consignees located in China.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
SPF 30 SUNSCREEN LOTION Active Ingredients Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4.0% Titanium Dioxide 2.5% Sunscreen, 53mL/1.8fl.oz., OTC, Distributed by: EVANS, Made in China
Batch or Lot Expiration Information
Lot# : 20180709, Exp 07/08/2020; 20180710, Exp 07/09/2020
Recall Number: D-1547-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
04-01-2019
08-07-2019
20,160
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NingBo Huize Commodity Co.,Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Foreign manufacturer located in China and distributed to seven consignees located in China.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
AMERICA'S ORIGINAL DUBBLE BUBBLE Pink Lemonade SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Batch or Lot Expiration Information
Lot# : 20181108, Exp 11/7/2020; 20181109, Exp 11/8/2020
Recall Number: D-1529-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
04-01-2019
08-07-2019
35,500
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NingBo Huize Commodity Co.,Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Foreign manufacturer located in China and distributed to seven consignees located in China.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Accent Care of New York Home Care Nursing Personal Care Hand Sanitizer (Ethyl Alcohol 62%), 0.33 oz/10 mL, OTC, Made in China
Batch or Lot Expiration Information
Lot# : 20170619, Exp 6/18/2019; 20170620, Exp 6/19/2019; 20170621, Exp 6/20/2019
Recall Number: D-1553-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
04-01-2019
08-07-2019
13,068
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NingBo Huize Commodity Co.,Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Foreign manufacturer located in China and distributed to seven consignees located in China.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
AIR HEADS BLUE RASPBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Batch or Lot Expiration Information
Lot# : 20181120, Exp 11/19/2020; 20181121, Exp 11/20/2020
Recall Number: D-1557-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
04-01-2019
08-07-2019
13,068
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NingBo Huize Commodity Co.,Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Foreign manufacturer located in China and distributed to seven consignees located in China.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
ICEE PEACH SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Batch or Lot Expiration Information
Lot# : 20181130, Exp 11/29/2020; 20181203, Exp 12/2/2020
Recall Number: D-1550-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
04-01-2019
08-07-2019
8,856
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NingBo Huize Commodity Co.,Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Foreign manufacturer located in China and distributed to seven consignees located in China.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
TOOTSIE ROLL FRUIT CHEWS LIME SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Batch or Lot Expiration Information
Lot# : 20181114, Exp 11/13/2020
Recall Number: D-1559-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
04-01-2019
08-07-2019
13,068
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NingBo Huize Commodity Co.,Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Foreign manufacturer located in China and distributed to seven consignees located in China.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
ICEE BLUE RASPBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Batch or Lot Expiration Information
Lot# : 20181206, Exp 12/5/2020; 20181207, Exp 12/6/2020
Recall Number: D-1549-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
04-01-2019
08-07-2019
8,856
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NingBo Huize Commodity Co.,Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Foreign manufacturer located in China and distributed to seven consignees located in China.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
TOOTSIE ROLL FRUIT CHEWS VANILLA SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Batch or Lot Expiration Information
Lot# : 20181113, Exp 11/12/2020
Recall Number: D-1542-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
04-01-2019
08-07-2019
18036
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NingBo Huize Commodity Co.,Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Foreign manufacturer located in China and distributed to seven consignees located in China.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
CHARMS BLOW POP CHERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Batch or Lot Expiration Information
Lot# : 20181025, Exp 10/24/2020; 20181026, Exp 10/25/2020
Recall Number: D-1556-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
04-01-2019
08-07-2019
13,068
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NingBo Huize Commodity Co.,Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Foreign manufacturer located in China and distributed to seven consignees located in China.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
ICEE LEMON LIME SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Batch or Lot Expiration Information
Lot# : 20181128, Exp 11/27/2020; 20181129, Exp 11/28/2020
Recall Number: D-1545-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
04-01-2019
08-07-2019
18036
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NingBo Huize Commodity Co.,Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Foreign manufacturer located in China and distributed to seven consignees located in China.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
CHARMS BLOW POP SOUR APPLE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Batch or Lot Expiration Information
Lot# : 20181102, Exp 11/1/2020; 20181105, Exp 11/4/2020
Recall Number: D-1544-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
04-01-2019
08-07-2019
18036
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NingBo Huize Commodity Co.,Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Foreign manufacturer located in China and distributed to seven consignees located in China.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
CHARMS BLOW POP BLUE RAZZ BERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Batch or Lot Expiration Information
Lot# : 20181031, Exp 10/28/2020; 20181101, Exp 10/31/2020
Recall Number: D-1555-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
04-01-2019
08-07-2019
13,068
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NingBo Huize Commodity Co.,Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Foreign manufacturer located in China and distributed to seven consignees located in China.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
AIR HEADS ORANGE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Batch or Lot Expiration Information
Lot# : 20181126, Exp 11/25/2020; 20181127, Exp 11/26/2020
Recall Number: D-1552-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
04-01-2019
08-07-2019
13,068
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NingBo Huize Commodity Co.,Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Foreign manufacturer located in China and distributed to seven consignees located in China.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
AIR HEADS STRAWBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Batch or Lot Expiration Information
Lot# : 20181116, Exp 11/15/2020; 20181119, Exp 11/18/2020
Recall Number: D-1530-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
04-01-2019
08-07-2019
52,160
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NingBo Huize Commodity Co.,Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Foreign manufacturer located in China and distributed to seven consignees located in China.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Good to Go Hand Sanitizer (Ethyl Alcohol 62%), 1 FL OZ (30 mL), OTC, Made in China for Cashco Distributors Inc. 6430 N. E. Columbia Blvd Portland OR 97218
Batch or Lot Expiration Information
Lot# : 20180601 Exp 5/31/2020, 20180604 Exp 6/3/2020, 20180820 Exp 8/19/2020, 20180821 Exp 8/20/2020, 20180822 Exp 8/21/2020
Recall Number: D-1531-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
04-01-2019
08-07-2019
5112
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NingBo Huize Commodity Co.,Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Foreign manufacturer located in China and distributed to seven consignees located in China.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Tootsie Roll POP GRAPE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed By: JFL Enterprises, Inc. Cleveland, Ohio 44102, Made in China
Batch or Lot Expiration Information
Lot# : 20181018, Exp 10/17/2020
Recall Number: D-1537-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
04-01-2019
08-07-2019
5112
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NingBo Huize Commodity Co.,Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Foreign manufacturer located in China and distributed to seven consignees located in China.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Tootsie Roll POP RASPBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Batch or Lot Expiration Information
Lot# : 20181017, Exp 10/16/2020
Recall Number: D-1554-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
04-01-2019
08-07-2019
13,068
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NingBo Huize Commodity Co.,Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Foreign manufacturer located in China and distributed to seven consignees located in China.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
AIR HEADS PINK LEMONADE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Batch or Lot Expiration Information
Lot# : 20181122, Exp 11/21/2020; 20181123, Exp 11/22/2020
Recall Number: D-1546-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
04-01-2019
08-07-2019
20160
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NingBo Huize Commodity Co.,Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Foreign manufacturer located in China and distributed to seven consignees located in China.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
AMERICA'S ORIGINAL DUBBLE BUBBLE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Batch or Lot Expiration Information
Lot# : 20181106, Exp 11/5/2020; 20181107, Exp 11/6/2020
Recall Number: D-1534-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
04-01-2019
08-07-2019
50,000
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NingBo Huize Commodity Co.,Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Foreign manufacturer located in China and distributed to seven consignees located in China.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Texas Home Health Home Care Hospice Personal Care Hand Sanitizer (Ethyl Alcohol 62%), 0.33 oz/10 mL, OTC, Made in China
Batch or Lot Expiration Information
Lot# : 20180410, Exp 4/9/2020; 20180411, Exp 4/10/2020; 20180830, Exp 8/29/2020; 20180831, Exp 8/30/2020
Recall Number: D-1540-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
04-01-2019
08-07-2019
3852
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NingBo Huize Commodity Co.,Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Foreign manufacturer located in China and distributed to seven consignees located in China.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
DOTS SCENTED ANTIBACTERIAL HAND GEL STRAWBRRY (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Batch or Lot Expiration Information
Lot# : 20181023, Exp 10/22/2020
Recall Number: D-1533-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
04-01-2019
08-07-2019
20, 000
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NingBo Huize Commodity Co.,Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Foreign manufacturer located in China and distributed to seven consignees located in China.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
festpak clearly fun SPF30 sunscreen lotion SPF 30 SUNSCREEN LOTION Active Ingredients Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4.0% Titanium Dioxide 2.5% Sunscreen Distributed by: festpak - Austin, TX 78732 Made in China
Batch or Lot Expiration Information
Lot# : 20181008, Exp 10/07/2020; 20181009, Exp 10/08/2020
Recall Number: D-1543-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
04-01-2019
08-07-2019
18036
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NingBo Huize Commodity Co.,Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Foreign manufacturer located in China and distributed to seven consignees located in China.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
CHARMS BLOW POP WATERMELON SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Batch or Lot Expiration Information
Lot# : 20181029, Exp 10/28/2020; 20181030, Exp 10/29/2020
Recall Number: D-1548-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
04-01-2019
08-07-2019
8,856
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NingBo Huize Commodity Co.,Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Foreign manufacturer located in China and distributed to seven consignees located in China.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
TOOTSIE ROLL FRUIT CHEWS LEMON SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Batch or Lot Expiration Information
Lot# : 20181112, Exp 11/11/2020
Recall Number: D-1536-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
04-01-2019
08-07-2019
5112
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NingBo Huize Commodity Co.,Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Foreign manufacturer located in China and distributed to seven consignees located in China.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Tootsie Roll POP CHOCOLATE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Batch or Lot Expiration Information
Lot# : 20181016, Exp 10/15/2020
Recall Number: D-1541-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
04-01-2019
08-07-2019
3852
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NingBo Huize Commodity Co.,Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Foreign manufacturer located in China and distributed to seven consignees located in China.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
DOTS SCENTED ANTIBACTERIAL HAND GEL LEMON (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Batch or Lot Expiration Information
Lot# : 20181024, Exp 10/23/2020
Recall Number: D-1538-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
04-01-2019
08-07-2019
3852
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
NingBo Huize Commodity Co.,Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Foreign manufacturer located in China and distributed to seven consignees located in China.
06-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
DOTS SCENTED ANTIBACTERIAL HAND GEL ORANGE (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Batch or Lot Expiration Information
Lot# : 20181019, Exp 10/18/2020
