Why it was recalled
CGMP Deviations: finished products were manufactured with poor quality water.
Product description
WipeEssentials Wet Wipes (benzalkonium chloride 0.13%), 30-count pouches, Dist. by Diamond Wipes Int'l, Inc., Chino, CA 91710, UPC 7 66670 03988 6.
Lot numbers, UPCs & expiration codes
Lot #: 7382A1, 7382B1, 7382A2, 7382B2, 7382A3, 7383A1, 7383B1, 7383A2, 7401A1, 7401B1, 7572A1, 7572B1, 7577B1, 7577A2, 7577B2, EXP 03/18; 7573B1, 7573A2, 7782A1, 7783A1, 7783B1, EXP 04/18; 7984B1, 7984A2, 7984B2, 8043A1, 8043B1, 8403A1, EXP 05/18; 8291A1, 8292B1, 8293A1, 8294B1, EXP 07/18; 8511A1, 8512B1, 8513B1, 8513A2, 8514A1, 8514B1, 8514A2, 8520A1, 8520B1, EXP 08/18; 8818A1, 8821B1, 8821A2, EXP 09/18
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-0630-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 2, 2018
- FDA report date
- Apr 25, 2018
- Quantity
- 5,148,792 pouches
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Diamond Wipes International, Inc.
Original FDA data
Every field from FDA enforcement report D-0630-2018, 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 #: 7382A1, 7382B1, 7382A2, 7382B2, 7382A3, 7383A1, 7383B1, 7383A2, 7401A1, 7401B1, 7572A1, 7572B1, 7577B1, 7577A2, 7577B2, EXP 03/18; 7573B1, 7573A2, 7782A1, 7783A1, 7783B1, EXP 04/18; 7984B1, 7984A2, 7984B2, 8043A1, 8043B1, 8403A1, EXP 05/18; 8291A1, 8292B1, 8293A1, 8294B1, EXP 07/18; 8511A1, 8512B1, 8513B1, 8513A2, 8514A1, 8514B1, 8514A2, 8520A1, 8520B1, EXP 08/18; 8818A1, 8821B1, 8821A2, EXP 09/18
- Postal code
- 91710-5542
- Report date
- Apr 25, 2018
- Product type
- Drugs
- Recall number
- D-0630-2018
- Classification
- Class II
- Recalling firm
- Diamond Wipes International, Inc.
- Product quantity
- 5,148,792 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
- WipeEssentials Wet Wipes (benzalkonium chloride 0.13%), 30-count pouches, Dist. by Diamond Wipes Int'l, Inc., Chino, CA 91710, UPC 7 66670 03988 6.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Apr 2, 2018
- Initial firm notification
- Letter
- Center classification date
- Apr 16, 2018