Home / Recalls / US Pharmaceuticals Inc. / D-1739-2019

D-1739-2019 Class II Terminated

Recalled by US Pharmaceuticals Inc. — Belleville, NJ

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

Other recalls by US Pharmaceuticals Inc.

  • D-0113-2021 Class II — CVS Health Hydrating Healing Ointment (Petrolatum 41%), Net Wt 3 OZ (85g), Distr (November 19, 2020)
  • D-1729-2019 Class II — Adult Glycerin Suppositories, Package Size 50-count suppositories, Distributed B (July 11, 2019)
  • D-1736-2019 Class II — CVS Health Glycerin Suppositories, 100- count box, Distributed by:Distributed by (July 11, 2019)
  • D-1730-2019 Class II — Adult Glycerin Suppositories, Package Size 100-count suppositories, Distributed (July 11, 2019)
  • D-1740-2019 Class II — Wonder Freeze Pain Releiving Gel with ILEX, Menthol 5%, packaged in a) 3 OZ /85 (July 11, 2019)
  • D-1726-2019 Class II — CVS Therapeutic Menthol Gel, 8 FL OZ (227 g) Distributed by: CVS Pharmacy, Inc. (July 11, 2019)
  • D-1725-2019 Class II — Eczema Lotion Hydrocortisone 1% / Anti-Itch Lotion, 3.5 oz (99.2 g) Distributed (July 11, 2019)
  • D-1727-2019 Class II — Children Glycerin Suppositories Laxative for ages 2 to 5. Package Size 25-count. (July 11, 2019)
  • D-1738-2019 Class II — Cool Hot Ice Analgesic Gel, 8 oz (227 g) Distributed by: Unipack Inc. Pittsburg, (July 11, 2019)
  • D-1737-2019 Class II — CRYO-273 Cold Pain Relieving Gel Roll-On 3 FL. OZ. (89 mL) Distributed By: CRYO- (July 11, 2019)