Wonder Freeze Pain Releiving Gel with ILEX recall: CGMP Deviations
Wonder Freeze Pain Releiving Gel with ILEX, Menthol 5%, packaged in a) 3 OZ /85 g (UPC 0 99528 35903 5); b) 4 OZ / 113 g (UPC 0 99528 31504 8); c) 16 OZ / 454 g (UPC 0 99528 31516 1); Manufactured For: Wonder Laboratories, 115 S.C.T. Ct., White House TN. 37188.
Why was Wonder Freeze Pain Releiving Gel with ILEX 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 # a) 21J18, EXP 07/2021 b) 42H18, EXP 06/2021; c) 32H18, EXP 6/2021
- Product
- Wonder Freeze Pain Releiving Gel with ILEX, Menthol 5%, packaged in a) 3 OZ /85 g (UPC 0 99528 35903 5); b) 4 OZ / 113 g (UPC 0 99528 31504 8); c) 16 OZ / 454 g (UPC 0 99528 31516 1); Manufactured For: Wonder Laboratories, 115 S.C.T. Ct., White House TN. 37188.
- Recalling firm
- US Pharmaceuticals Inc.
- Quantity
- 147 cases
- Distribution
- Distributed Nationwide in the USA
- Recall date
- August 21, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)