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.
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