Drug & medication recalls

AIR HEADS BLUE RASPBERRY SCENTED ANTIBACTERIAL HAND GEL recalled over manufacturing violations

Recall date
April 1, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
NingBo Huize Commodity Co.,Ltd. recalls AIR HEADS BLUE RASPBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: J…
Recall number
D-1553-2019
FDA classification
Class III
Brand / firm
NingBo Huize Commodity Co.,Ltd.
Sold / distributed
Foreign manufacturer located in China and distributed to seven consignees located in China.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.

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