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D-0117-2021 Class II Terminated

Recalled by Asiaticon, SA de CV — Ciudad De Mexico, N/A

FDA drug recall D-0117-2021 was initiated by Asiaticon, SA de CV on August 25, 2020 and is designated Class II. Reason for recall: Lack of CGMPs: The recall status is terminated (terminated May 17, 2023). Affected quantity: 111,500 units.

Recall Details

Product Type: Drugs
Report Date: December 16, 2020
Initiation Date: August 25, 2020
Termination Date: May 17, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 111,500 units

Product Description

Protz real protection Antibacterial Hand Sanitizer, Ethyl Alcohol 70%, 13.5 FL OZ (400 mL), Distributed by: Safety-Med Products, Inc. Burlington, WI 53105 Made in Mexico by Asiaticon S.A. de C.V. Conkal No. 62, Mexico, Ciudad de Mexico 14200, Mexico NDC: 75192-600-02 UPC 7 503019 005002

Reason for Recall

Lack of CGMPs:

Distribution Pattern

Distributed in Texas

Code Information

All lots.