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Recall Observatory FDA recall evidence

Drug 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.

D-1550-2019

April 01, 2019

Class III

Product summary

Firm
NingBo Huize Commodity Co.,Ltd.
Event
Event 83018
Status
Terminated
Classification
Class III
Quantity
8,856
Official record key
drug-enforcement:D-1550-2019

Official wording

Reason: 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.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP deviations