Cool Hot Ice Analgesic Gel recall: CGMP Deviations
Cool Hot Ice Analgesic Gel, 8 oz (227 g) Distributed by: Unipack Inc. Pittsburg, PA 15239, USA. UPC 7 51393 00608 6
Why was Cool Hot Ice Analgesic Gel 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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 14L18, EXP 09/2020
- Product
- 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.
- Quantity
- 246 cases
- Distribution
- Distributed Nationwide in the USA
- Recall date
- August 21, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)