FDA Drug Recalls

Recalls / Class III

Class IIID-1473-2016

Product

CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47476-8, Shade 01 (VF-N)

Affected lot / code info
all lots

Why it was recalled

Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.

Recalling firm

Firm
Clinique International
Notification channel
E-Mail
Type
Voluntary: Firm initiated
Address
767 5th Ave, N/A, New York, New York 10153-0023

Distribution

Quantity
1,771,244 bottles for all shades
Distribution pattern
Nationwide

Timeline

Recall initiated
2016-05-17
FDA classified
2016-08-26
Posted by FDA
2016-09-07
Terminated
2018-06-14
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1473-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.