FDAFDA · Food and drugs·Recall number D-1738-2019
Cool Hot Ice Analgesic Gel, 8 oz (227 g) Distributed by: Unipack Inc. Pittsburg, PA 15239, USA. UPC 7 51393 00608 6
Published August 21, 2019 · Recall initiated: July 11, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- US Pharmaceuticals Inc.
- Distributor
- Distributed Nationwide in the USA
- Lot
- Lot # 14L18, EXP 09/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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