FDA Drug Recalls

Recalls / Class III

Class IIID-1101-2017

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.

Affected lot / code info
Lot #: 130917, Exp 09/13/2017; 310318, Exp 03/31/2018; 270718, Exp 07/27/2018; 081118, Exp 11/08/2018.

Why it was recalled

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

Recalling firm

Firm
Linde Eckstein Gmbh + Co KG
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
Flurstrasse 27a-35, N/A, Oberasbach, N/A N/A, Germany

Distribution

Quantity
N/A
Distribution pattern
Distributed throughout the United States

Timeline

Recall initiated
2017-07-17
FDA classified
2017-08-17
Posted by FDA
2017-08-23
Terminated
2018-02-28
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1101-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class III recall: drug · FDA Drug Recalls