Drug product
Acne Shave 3 Step Shaving System, contains one tube Acne Shave (salicylic acid) Shave Cream Acne Shield, one tube Acne Shave Post-Shave Moisturizer (salicylic acid), 0.5% tube, and one Power Shaver per box, Distributed by: United Exchange Corp., 17311 Valley View Blvd, Cerritos CA 90703 USA, UPC 7 80707 73114 7.
D-0861-2018
Product summary
- Event
- Event 80184
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,932 boxes
- Official record key
drug-enforcement:D-0861-2018
Official wording
Reason: CGMP Deviations: products may be contaminated with bacteria.
Code information: All lots
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations