Reported Aug 21, 2019 · Terminated
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…
US Pharmaceuticals Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: US Pharmaceuticals Inc. · 681 Main St Ste 27 · Belleville, NJ · 07109-3471
Is this the product you have?
6 of 6 products
| # | Product as published |
|---|---|
| 1 | 3 OZ./85 g (UPC 0 52301 35903 5) |
| 2 | 4 OZ/ 113 g (UPC 0 52301 36504 3) |
| 3 | 32 OZ/ 907 g (UPC 0 52301 36532 6) |
| 4 | 16 OZ/ 454 g (UPC 0 52301 36516 6) |
| 5 | 128 OZ/ 3629 g (UPC 0 52301 36512 |
| 6 | Manufactured for: Dee Cee Laboratories, Inc. 304 Dee Cee Rd., White House, TN 37188. |
- Lot codes and dates
Lot # 27H18EXP 06/202132H18EXP 06/202142H18EXP 06/202121J18EXP 07/2021
- Amount recalled
- 2192 cases
This recall covers 18 products
The agency filed one notice per product. You are reading one of them; the other 17 are below.
5 more are in the archive.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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