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Recall Observatory FDA recall evidence

Drug product

Make Up Transparent pastel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03210, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032104.

D-1101-2017

July 17, 2017

Class III

Product summary

Firm
Linde Eckstein Gmbh + Co KG
Event
Event 77840
Status
Terminated
Classification
Class III
Quantity
N/A
Official record key
drug-enforcement:D-1101-2017

Official wording

Reason: Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.

Code information: Lot #: 130917, Exp 09/13/2017; 310318, Exp 03/31/2018; 270718, Exp 07/27/2018; 081118, Exp 11/08/2018.

Distribution pattern: Distributed throughout the United States

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent