Drug product
Glytone Acne, acne treatment facial cleanser, 2% Salicylic Acid, 200 mL/6.7 FL Oz Bottle, Distributed by Genesis Pharmaceuticals, Inc. a subsidiary of Pierre Fabre, Parsippany, NJ 07054, UPC 3 04760-00413-2
D-1285-2014
Product summary
- Event
- Event 68098
- Status
- Terminated
- Classification
- Class III
- Quantity
- 461 Bottles
- Official record key
drug-enforcement:D-1285-2014
Official wording
Reason: Failed Stability Specifications: Out of specification results for viscosity in one lot of Glytone Acne Treatment Facial Cleanser.
Code information: Lot 54, Exp: 1/14/2016
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Out of specification