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Recall Observatory FDA recall evidence

Drug 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

D-1317-2014

April 29, 2014

Class II

Product summary

Firm
Flawless Beauty LLC
Event
Event 68158
Status
Completed
Classification
Class II
Quantity
unknown
Official record key
drug-enforcement:D-1317-2014

Official wording

Reason: Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.

Code information: Lot #: UB302, Exp 05/12/15

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.