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.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot # a) 21J18, EXP 07/2021 b) 42H18, EXP 06/2021; c) 32H18, EXP 6/2021
Where it was sold
Distributed Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1740-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 11, 2019
- FDA report date
- Aug 21, 2019
- Quantity
- 147 cases
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- US Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1740-2019, exactly as published.
Show all FDA fields
- City
- Belleville
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 83316
- Address
- 681 Main St Ste 27
- Code information
- Lot # a) 21J18, EXP 07/2021 b) 42H18, EXP 06/2021; c) 32H18, EXP 6/2021
- Postal code
- 07109-3471
- Report date
- Aug 21, 2019
- Product type
- Drugs
- Recall number
- D-1740-2019
- Classification
- Class II
- Recalling firm
- US Pharmaceuticals Inc.
- Product quantity
- 147 cases
- Termination date
- Jun 25, 2020
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Jul 11, 2019
- Initial firm notification
- Letter
- Center classification date
- Aug 13, 2019