Drug product
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.
D-1739-2019
Product summary
- Event
- Event 83316
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2192 cases
- Official record key
drug-enforcement:D-1739-2019
Official wording
Reason: CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Code information: Lot # 27H18, EXP 06/2021; 32H18, EXP 06/2021; 42H18, EXP 06/2021; 21J18, EXP 07/2021
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Potency or specification failure
Out of Specification