PlainRecordsFDA · Drug recall
ACURE… and 1 more product
- Date
- April 25, 2018
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Terminated
- Filed by
- Diamond Wipes International, Inc.
- Reason
- CGMP Deviations: finished products were manufactured with poor quality water.
- Distribution pattern
- Nationwide in the USA.
2 products in this recall
ACURE…
- Product
- 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.
- Quantity
- 51,840 pouches
- Codes and lots
- Lot #: A96, A106, B106, EXP 09/18; C27, EXP 01/19
- Recall started
- April 2, 2018
- Recall number
- D-0629-2018
WipeEssentials Wet Wipes (benzalkonium chloride 0.13%)…
- Product
- 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.
- Quantity
- 5,148,792 pouches
- Codes and lots
- 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
- Recall started
- April 2, 2018
- Recall number
- D-0630-2018
What should I do? Medicine recall: what to do
Source: FDA · Drug enforcement reports, recall numbers D-0629-2018, D-0630-2018. The agency record governs; check it and the company before acting.