Kool Comfort Cooling Pain Relief, 5% Menthol, Packaged in a) 3 OZ./85 g (UPC 0 52301 35903 5); b) 4 OZ/ 113 g (UPC 0 52301 36504 3); c) 32 OZ/ 907 g (UPC 0 52301 36532 6); d) 16 OZ/ 454 g (UPC 0 52301 36516 6); e) 128 OZ/ 3629 g (UPC 0 52301 36512 8) Manufactured for: Dee Cee Laboratories, Inc. 304 Dee Cee Rd., White House, TN 37188.
Reported: August 21, 2019 Initiated: July 11, 2019 #D-1739-2019
Product Description
Kool Comfort Cooling Pain Relief, 5% Menthol, Packaged in a) 3 OZ./85 g (UPC 0 52301 35903 5); b) 4 OZ/ 113 g (UPC 0 52301 36504 3); c) 32 OZ/ 907 g (UPC 0 52301 36532 6); d) 16 OZ/ 454 g (UPC 0 52301 36516 6); e) 128 OZ/ 3629 g (UPC 0 52301 36512 8) Manufactured for: Dee Cee Laboratories, Inc. 304 Dee Cee Rd., 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.
Details
- Recalling Firm
- US Pharmaceuticals Inc.
- Units Affected
- 2192 cases
- Distribution
- Distributed Nationwide in the USA
- Location
- Belleville, NJ
Frequently Asked Questions
What product was recalled? ▼
Kool Comfort Cooling Pain Relief, 5% Menthol, Packaged in a) 3 OZ./85 g (UPC 0 52301 35903 5); b) 4 OZ/ 113 g (UPC 0 52301 36504 3); c) 32 OZ/ 907 g (UPC 0 52301 36532 6); d) 16 OZ/ 454 g (UPC 0 52301 36516 6); e) 128 OZ/ 3629 g (UPC 0 52301 36512 8) Manufactured for: Dee Cee Laboratories, Inc. 304 Dee Cee Rd., White House, TN 37188.. Recalled by US Pharmaceuticals Inc.. Units affected: 2192 cases.
Why was this product recalled? ▼
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 21, 2019. Severity: Moderate. Recall number: D-1739-2019.
Related Recalls
NHTSA Critical
LEXUS 2025: POWER TRAIN:AUTOMATIC TRANSMISSION
LEXUS · 2026-02-18
NHTSA Critical
CADILLAC,CHEVROLET,GMC 2022: POWER TRAIN:AUTOMATIC TRANSMISSION:CONTROL MODULE:SOFTWARE
CADILLAC,CHEVROLET,GMC · 2026-02-13
NHTSA Critical
CHEVROLET,GMC 2020-2022: POWER TRAIN:AUTOMATIC TRANSMISSION:CONTROL MODULE:SOFTWARE
CHEVROLET,GMC · 2026-02-12
NHTSA Critical
CADILLAC 2024: BACK OVER PREVENTION:SOFTWARE
CADILLAC · 2026-02-12
NHTSA Critical
NISSAN 2024-2025: FUEL SYSTEM, GASOLINE:FUEL INJECTION SYSTEM:THROTTLEBODY/MANIFOLD
NISSAN · 2026-02-12