Cool Hot Ice Analgesic Gel, 8 oz (227 g) Distributed by: Unipack Inc. Pittsburg, PA…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
What was recalled
Cool Hot Ice Analgesic Gel, 8 oz (227 g) Distributed by: Unipack Inc. Pittsburg, PA 15239, USA. UPC 7 51393 00608 6
- Recalling firm
- US Pharmaceuticals Inc.
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1738-2019
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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