PlainRecalls
FDA Drug Moderate Class II Completed

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

Reported: May 21, 2014 Initiated: April 29, 2014 #D-1317-2014

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.

Details

Recalling Firm
Flawless Beauty LLC
Units Affected
unknown
Distribution
Nationwide
Location
Asbury Park, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Flawless Beauty LLC. Units affected: unknown.
Why was this product recalled?
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 21, 2014. Severity: Moderate. Recall number: D-1317-2014.