FDA recall D-1740-2019

Product

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.

Reason for recall

CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

Distribution

Distributed Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2019-07-11

Report date

2019-08-21

Termination date

2020-06-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Belleville, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1740-2019