D-1317-2014 Class II
Recall Details
- Product Type
- Drugs
- Report Date
- May 21, 2014
- Initiation Date
- April 29, 2014
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- unknown
Product Description
Tatiomax (reduced glutathione/hydrolyzed collagen) powder for injection vials, 1200 mg/200 mg, 10-count vials per box, Manufactured by: Sujie Pharmaceutical Ltd., Tokyo, Japan, UPC 4973430081576
Reason for Recall
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.
Distribution Pattern
Nationwide
Code Information
Lot #: UB302, Exp 05/12/15