D-0584-2018 Class III Terminated
FDA drug recall D-0584-2018 was initiated by Oxygen Development Llc on January 24, 2018 and is designated Class III. Reason for recall: Superpotent drug: failed assay throughout the stick after 6 months stability. The recall status is terminated (terminated April 3, 2019). Affected quantity: 12216 sticks.
Recall Details
- Product Type
- Drugs
- Report Date
- March 14, 2018
- Initiation Date
- January 24, 2018
- Termination Date
- April 3, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12216 sticks
Product Description
Life Brand Clear Action Acne Treatment Concealer Stick (Salicylic acid), 1.9g, Imported for: Shoppers Drug Mart Pharmaprix Toronto, M2J4W8, UPC 057800062653
Reason for Recall
Superpotent drug: failed assay throughout the stick after 6 months stability.
Distribution Pattern
Canada
Code Information
Lot #: 060E