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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83018

36 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 01, 2019
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
NingBo Huize Commodity Co.,Ltd.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

36 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 36

Accent Care of New York Home Care Nursing Personal Care Hand Sanitizer (Ethyl Alcohol 62%), 0.33 oz/10 mL, OTC, Made in China

D-1529-2019
Recall number
D-1529-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
35,500

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 20170619, Exp 6/18/2019; 20170620, Exp 6/19/2019; 20170621, Exp 6/20/2019

Distribution pattern

Foreign manufacturer located in China and distributed to seven consignees located in China.

drug · product 2 of 36

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

D-1530-2019
Recall number
D-1530-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
52,160

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code 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

Distribution pattern

Foreign manufacturer located in China and distributed to seven consignees located in China.

drug · product 3 of 36

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

D-1531-2019
Recall number
D-1531-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
5112

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 20181018, Exp 10/17/2020

Distribution pattern

Foreign manufacturer located in China and distributed to seven consignees located in China.

drug · product 4 of 36

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

D-1532-2019
Recall number
D-1532-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
10, 000

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 20180709, Exp 07/08/2020; 20180710, Exp 07/09/2020

Distribution pattern

Foreign manufacturer located in China and distributed to seven consignees located in China.

drug · product 5 of 36

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

D-1533-2019
Recall number
D-1533-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
20, 000

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 20181008, Exp 10/07/2020; 20181009, Exp 10/08/2020

Distribution pattern

Foreign manufacturer located in China and distributed to seven consignees located in China.

drug · product 6 of 36

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

D-1534-2019
Recall number
D-1534-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
50,000

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

Foreign manufacturer located in China and distributed to seven consignees located in China.

drug · product 7 of 36

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.

D-1535-2019
Recall number
D-1535-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
5112

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 20181015, Exp 10/14/2020

Distribution pattern

Foreign manufacturer located in China and distributed to seven consignees located in China.

drug · product 8 of 36

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.

D-1536-2019
Recall number
D-1536-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
5112

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 20181016, Exp 10/15/2020

Distribution pattern

Foreign manufacturer located in China and distributed to seven consignees located in China.

drug · product 9 of 36

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.

D-1537-2019
Recall number
D-1537-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
5112

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 20181017, Exp 10/16/2020

Distribution pattern

Foreign manufacturer located in China and distributed to seven consignees located in China.

drug · product 10 of 36

DOTS SCENTED ANTIBACTERIAL HAND GEL ORANGE (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.

D-1538-2019
Recall number
D-1538-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
3852

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 20181019, Exp 10/18/2020

Distribution pattern

Foreign manufacturer located in China and distributed to seven consignees located in China.

drug · product 11 of 36

DOTS SCENTED ANTIBACTERIAL HAND GEL LIME (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.

D-1539-2019
Recall number
D-1539-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
3852

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 20181022, Exp 10/21/2020

Distribution pattern

Foreign manufacturer located in China and distributed to seven consignees located in China.

drug · product 12 of 36

DOTS SCENTED ANTIBACTERIAL HAND GEL STRAWBRRY (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.

D-1540-2019
Recall number
D-1540-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
3852

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 20181023, Exp 10/22/2020

Distribution pattern

Foreign manufacturer located in China and distributed to seven consignees located in China.

drug · product 13 of 36

DOTS SCENTED ANTIBACTERIAL HAND GEL LEMON (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.

D-1541-2019
Recall number
D-1541-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
3852

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 20181024, Exp 10/23/2020

Distribution pattern

Foreign manufacturer located in China and distributed to seven consignees located in China.

drug · product 14 of 36

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.

D-1542-2019
Recall number
D-1542-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
18036

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 20181025, Exp 10/24/2020; 20181026, Exp 10/25/2020

Distribution pattern

Foreign manufacturer located in China and distributed to seven consignees located in China.

drug · product 15 of 36

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.

D-1543-2019
Recall number
D-1543-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
18036

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 20181029, Exp 10/28/2020; 20181030, Exp 10/29/2020

Distribution pattern

Foreign manufacturer located in China and distributed to seven consignees located in China.

drug · product 16 of 36

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.

D-1544-2019
Recall number
D-1544-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
18036

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 20181031, Exp 10/28/2020; 20181101, Exp 10/31/2020

Distribution pattern

Foreign manufacturer located in China and distributed to seven consignees located in China.

drug · product 17 of 36

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.

D-1545-2019
Recall number
D-1545-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
18036

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 20181102, Exp 11/1/2020; 20181105, Exp 11/4/2020

Distribution pattern

Foreign manufacturer located in China and distributed to seven consignees located in China.

drug · product 18 of 36

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.

D-1546-2019
Recall number
D-1546-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
20160

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 20181106, Exp 11/5/2020; 20181107, Exp 11/6/2020

Distribution pattern

Foreign manufacturer located in China and distributed to seven consignees located in China.

drug · product 19 of 36

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.

D-1547-2019
Recall number
D-1547-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
20,160

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 20181108, Exp 11/7/2020; 20181109, Exp 11/8/2020

Distribution pattern

Foreign manufacturer located in China and distributed to seven consignees located in China.

drug · product 20 of 36

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.

D-1548-2019
Recall number
D-1548-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
8,856

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 20181112, Exp 11/11/2020

Distribution pattern

Foreign manufacturer located in China and distributed to seven consignees located in China.

drug · product 21 of 36

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.

D-1549-2019
Recall number
D-1549-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
8,856

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 20181113, Exp 11/12/2020

Distribution pattern

Foreign manufacturer located in China and distributed to seven consignees located in China.

drug · product 22 of 36

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.

D-1550-2019
Recall number
D-1550-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
8,856

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 20181114, Exp 11/13/2020

Distribution pattern

Foreign manufacturer located in China and distributed to seven consignees located in China.

drug · product 23 of 36

TOOTSIE ROLL SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.

D-1551-2019
Recall number
D-1551-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
8,856

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 20181115, Exp 11/14/2020

Distribution pattern

Foreign manufacturer located in China and distributed to seven consignees located in China.

drug · product 24 of 36

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.

D-1552-2019
Recall number
D-1552-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
13,068

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 20181116, Exp 11/15/2020; 20181119, Exp 11/18/2020

Distribution pattern

Foreign manufacturer located in China and distributed to seven consignees located in China.

drug · product 25 of 36

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.

D-1553-2019
Recall number
D-1553-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
13,068

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 20181120, Exp 11/19/2020; 20181121, Exp 11/20/2020

Distribution pattern

Foreign manufacturer located in China and distributed to seven consignees located in China.

drug · product 26 of 36

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.

D-1554-2019
Recall number
D-1554-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
13,068

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 20181122, Exp 11/21/2020; 20181123, Exp 11/22/2020

Distribution pattern

Foreign manufacturer located in China and distributed to seven consignees located in China.

drug · product 27 of 36

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.

D-1555-2019
Recall number
D-1555-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
13,068

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 20181126, Exp 11/25/2020; 20181127, Exp 11/26/2020

Distribution pattern

Foreign manufacturer located in China and distributed to seven consignees located in China.

drug · product 28 of 36

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.

D-1556-2019
Recall number
D-1556-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
13,068

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 20181128, Exp 11/27/2020; 20181129, Exp 11/28/2020

Distribution pattern

Foreign manufacturer located in China and distributed to seven consignees located in China.

drug · product 29 of 36

ICEE PEACH SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.

D-1557-2019
Recall number
D-1557-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
13,068

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 20181130, Exp 11/29/2020; 20181203, Exp 12/2/2020

Distribution pattern

Foreign manufacturer located in China and distributed to seven consignees located in China.

drug · product 30 of 36

ICEE CHERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.

D-1558-2019
Recall number
D-1558-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
13,068

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 20181204, Exp 12/3/2020; 20181205, Exp 12/4/2020

Distribution pattern

Foreign manufacturer located in China and distributed to seven consignees located in China.

drug · product 31 of 36

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.

D-1559-2019
Recall number
D-1559-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
13,068

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 20181206, Exp 12/5/2020; 20181207, Exp 12/6/2020

Distribution pattern

Foreign manufacturer located in China and distributed to seven consignees located in China.

drug · product 32 of 36

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.

D-1560-2019
Recall number
D-1560-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
13,068

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 20181210, Exp 12/09/2020

Distribution pattern

Foreign manufacturer located in China and distributed to seven consignees located in China.

drug · product 33 of 36

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.

D-1561-2019
Recall number
D-1561-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
13,068

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 20181211, Exp 12/10/2020

Distribution pattern

Foreign manufacturer located in China and distributed to seven consignees located in China.

drug · product 34 of 36

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.

D-1562-2019
Recall number
D-1562-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
13,068

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 20181212, Exp 12/11/2020

Distribution pattern

Foreign manufacturer located in China and distributed to seven consignees located in China.

drug · product 35 of 36

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.

D-1563-2019
Recall number
D-1563-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
13,068

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 20181213, Exp 12/12/2020

Distribution pattern

Foreign manufacturer located in China and distributed to seven consignees located in China.

drug · product 36 of 36

Lemon Hand Sanitizer (Alcohol 62%), 30 mL / 1.0 fl.oz, OTC, Made in China.

D-1564-2019
Recall number
D-1564-2019
Initiated
April 01, 2019
Classification
Class III
Status
Terminated
Quantity
126,500

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

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

Distribution pattern

Foreign manufacturer located in China and distributed to seven consignees located in China.