Drug 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.
D-0629-2018
Product summary
- Event
- Event 79758
- Status
- Terminated
- Classification
- Class II
- Quantity
- 51,840 pouches
- Official record key
drug-enforcement:D-0629-2018
Official wording
Reason: CGMP Deviations: finished products were manufactured with poor quality water.
Code information: Lot #: A96, A106, B106, EXP 09/18; C27, EXP 01/19
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations