Multi-event April 2018 FDA Recall Drug by Diamond Wipes International, Inc.
This Multi-event Class II drug recall was voluntarily initiated by Diamond Wipes International, Inc. on April 2, 2018 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0629-2018
CGMP Deviations: finished products were manufactured with poor quality water.
04-02-2018
04-25-2018
51,840 pouches
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Diamond Wipes International, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA.
01-14-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# : A96, A106, B106, EXP 09/18; C27, EXP 01/19
Recall Number: D-0630-2018
CGMP Deviations: finished products were manufactured with poor quality water.
04-02-2018
04-25-2018
5,148,792 pouches
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Diamond Wipes International, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA.
01-14-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration 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
