FDA-Drug2019-08-21Class II
Wonder Freeze Pain Releiving Gel with ILEX, Menthol 5%, packaged in a) 3 OZ /85 g (UPC 0 99528 35903 5); b) 4 OZ / 113 g (UPC 0 99528 31504 8); c) 16 OZ / 454 g (UPC 0 99528 31516 1); Manufactured For: Wonder Laboratories, 115 S.C.T. Ct., White House TN. 37188.
US Pharmaceuticals Inc.
Hazard
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Sold states
Distributed Nationwide in the USA
Affected count
147 cases
Manufactured in
681 Main St Ste 27, N/A, Belleville, NJ, United States
Products
Wonder Freeze Pain Releiving Gel with ILEX, Menthol 5%, packaged in a) 3 OZ /85 g (UPC 0 99528 35903 5); b) 4 OZ / 113 g (UPC 0 99528 31504 8); c) 16 OZ / 454 g (UPC 0 99528 31516 1); Manufactured For: Wonder Laboratories, 115 S.C.T. Ct., White House TN. 37188.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1740-2019Don't want to check this manually?
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