D-0629-2018 Class II Terminated
FDA drug recall D-0629-2018 was initiated by Diamond Wipes International, Inc. on April 2, 2018 and is designated Class II. Reason for recall: CGMP Deviations: finished products were manufactured with poor quality water. The recall status is terminated (terminated January 14, 2019). Affected quantity: 51,840 pouches.
Recall Details
- Product Type
- Drugs
- Report Date
- April 25, 2018
- Initiation Date
- April 2, 2018
- Termination Date
- January 14, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 51,840 pouches
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.
Reason for Recall
CGMP Deviations: finished products were manufactured with poor quality water.
Distribution Pattern
Nationwide in the USA.
Code Information
Lot #: A96, A106, B106, EXP 09/18; C27, EXP 01/19