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D-1591-2020 Class II Terminated

Recalled by GRUPO YACANA MEXICO SAS DE CV — Guadalupe, N/A

FDA drug recall D-1591-2020 was initiated by GRUPO YACANA MEXICO SAS DE CV on August 18, 2020 and is designated Class II. Reason for recall: cGMP Deviations The recall status is terminated (terminated May 17, 2023). Affected quantity: 43,728 bottles.

Recall Details

Product Type
Drugs
Report Date
September 30, 2020
Initiation Date
August 18, 2020
Termination Date
May 17, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
43,728 bottles

Product Description

Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufactured by: Greensys of North America LLC. 5001 W Military Hwy Ste 100 McAllen, TX USA 78503, NDC# 76562-000-85, UPC 6 64213 64350 0

Reason for Recall

cGMP Deviations

Distribution Pattern

TX

Code Information

All lots

Other recalls by GRUPO YACANA MEXICO SAS DE CV

  • D-1590-2020 Class II — Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufacture (August 18, 2020)

FDA data resources