Why it was recalled
CGMP Deviations: finished products were manufactured with poor quality water.
Product description
ACURE, clarifying acne, glycolic + zinc (salicyclic acid 0.5%) towelettes, 30-count pouch, Distributed by Better Planet Brands, Fort Lauderdale, FL 33316, UPC 8 54049 00358 0.
Lot numbers, UPCs & expiration codes
Lot #: A96, A106, B106, EXP 09/18; C27, EXP 01/19
Where it was sold
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-0629-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 2, 2018
- FDA report date
- Apr 25, 2018
- Quantity
- 51,840 pouches
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Diamond Wipes International, Inc.
Original FDA data
Every field from FDA enforcement report D-0629-2018, exactly as published.
Show all FDA fields
- City
- Chino
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 79758
- Address
- 4651 Schaefer Ave
- Code information
- Lot #: A96, A106, B106, EXP 09/18; C27, EXP 01/19
- Postal code
- 91710-5542
- Report date
- Apr 25, 2018
- Product type
- Drugs
- Recall number
- D-0629-2018
- Classification
- Class II
- Recalling firm
- Diamond Wipes International, Inc.
- Product quantity
- 51,840 pouches
- Termination date
- Jan 14, 2019
- Reason for recall
- CGMP Deviations: finished products were manufactured with poor quality water.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ACURE, clarifying acne, glycolic + zinc (salicyclic acid 0.5%) towelettes, 30-count pouch, Distributed by Better Planet Brands, Fort Lauderdale, FL 33316, UPC 8 54049 00358 0.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Apr 2, 2018
- Initial firm notification
- Letter
- Center classification date
- Apr 16, 2018