D-1741-2019 Class II Terminated
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
- 314 cases
Product Description
CRYO-273 Cold Pain Relieving Gel 128 FL. OZ. Distributed By: CRYO-273.com Tampa, FL 33629. UPC 8 15290 01550 2
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 #'s 13K17 EXP 08/2019, 03L17 EXP 09/2019, 74H18 EXP 06/2020, 18J18 EXP 06/2020