Recalls / Class II
Class IID-1317-2014
Product
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
- Affected lot / code info
- Lot #: UB302, Exp 05/12/15
Why it was recalled
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.
Recalling firm
- Firm
- Flawless Beauty LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 1215 Main St, Asbury Park, New Jersey 07712-5940
Distribution
- Quantity
- unknown
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-04-29
- FDA classified
- 2014-05-13
- Posted by FDA
- 2014-05-21
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-1317-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.