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.
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.
Lot numbers, UPCs & expiration codes
Lot # 27H18, EXP 06/2021; 32H18, EXP 06/2021; 42H18, EXP 06/2021; 21J18, EXP 07/2021
Where it was sold
Distributed Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1739-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 11, 2019
- FDA report date
- Aug 21, 2019
- Quantity
- 2192 cases
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- US Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1739-2019, exactly as published.
Show all FDA fields
- City
- Belleville
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 83316
- Address
- 681 Main St Ste 27
- Code information
- Lot # 27H18, EXP 06/2021; 32H18, EXP 06/2021; 42H18, EXP 06/2021; 21J18, EXP 07/2021
- Postal code
- 07109-3471
- Report date
- Aug 21, 2019
- Product type
- Drugs
- Recall number
- D-1739-2019
- Classification
- Class II
- Recalling firm
- US Pharmaceuticals Inc.
- Product quantity
- 2192 cases
- Termination date
- Jun 25, 2020
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Jul 11, 2019
- Initial firm notification
- Letter
- Center classification date
- Aug 13, 2019