D-1739-2019 Class II Terminated
FDA drug recall D-1739-2019 was initiated by US Pharmaceuticals Inc. on July 11, 2019 and is designated Class II. 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. The recall status is terminated (terminated June 25, 2020). Affected quantity: 2192 cases.
Recall Details
- Product Type
- Drugs
- Report Date
- August 21, 2019
- Initiation Date
- July 11, 2019
- Termination Date
- June 25, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2192 cases
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.
Distribution Pattern
Distributed Nationwide in the USA
Code Information
Lot # 27H18, EXP 06/2021; 32H18, EXP 06/2021; 42H18, EXP 06/2021; 21J18, EXP 07/2021