FDA-Drug2019-07-31Class II

AbeeMed cream (Menthol 1.48% and Histamine DHCL 0.05%), 2 OZ jar, Manufactured exclusively for: Cas, P.O. Box 520248, Miami, FL 33152, UPC 8 50993 00402 4.

Pharma-Natural Inc.
Hazard

CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.

Sold states
Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
Affected count
19422 jars
Manufactured in
14500 Nw 60th Ave Bldg 7f, N/A, Miami Lakes, FL, United States
Products
AbeeMed cream (Menthol 1.48% and Histamine DHCL 0.05%), 2 OZ jar, Manufactured exclusively for: Cas, P.O. Box 520248, Miami, FL 33152, UPC 8 50993 00402 4.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1493-2019

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