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Recall Observatory FDA recall evidence

Drug 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.

D-0630-2018

April 02, 2018

Class II

Product summary

Firm
Diamond Wipes International, Inc.
Event
Event 79758
Status
Terminated
Classification
Class II
Quantity
5,148,792 pouches
Official record key
drug-enforcement:D-0630-2018

Official wording

Reason: CGMP Deviations: finished products were manufactured with poor quality water.

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

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations