Recalls / Class III
Class IIID-1475-2016
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. 20714-47478-2, Shade 03 (MF-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
- 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-1475-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.