Home / Recalls / US Pharmaceuticals Inc. / D-0427-2019

D-0427-2019 Class II Terminated

Recalled by US Pharmaceuticals Inc. — Belleville, NJ

Recall Details

Product Type
Drugs
Report Date
February 13, 2019
Initiation Date
December 7, 2018
Termination Date
November 6, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7020 units

Product Description

Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a) 2 oz tubes (NDC 53329-302-14) and b) 6 oz tubes (NDC 53329-302-41), Medline Industries Inc., Manufactured for Medline Industries Inc., Mundelien, IL 60060.

Reason for Recall

GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample

Distribution Pattern

Nationwide within the United States

Code Information

Lot # a) and b): 44G17, Exp. 05/2019

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-1739-2019 Class II — Kool Comfort Cooling Pain Relief, 5% Menthol, Packaged in a) 3 OZ./85 g (UPC 0 (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-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-1726-2019 Class II — CVS Therapeutic Menthol Gel, 8 FL OZ (227 g) Distributed by: CVS Pharmacy, Inc. (July 11, 2019)
  • D-1729-2019 Class II — Adult Glycerin Suppositories, Package Size 50-count suppositories, Distributed B (July 11, 2019)
  • D-1724-2019 Class II — CVS Health Glycerin Suppositories, 50-count box, Distributed by: CVS Pharmacy, I (July 11, 2019)
  • D-1730-2019 Class II — Adult Glycerin Suppositories, Package Size 100-count suppositories, Distributed (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)