Multi-event May 2016 FDA Recall Drug by Clinique International

This Multi-event Class III drug recall was voluntarily initiated by Clinique International on May 17, 2016 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1478-2016 TERMINATED D-1475-2016 TERMINATED D-1474-2016 TERMINATED D-1476-2016 TERMINATED D-1473-2016 TERMINATED D-1477-2016 TERMINATED

Recall Number: D-1478-2016

Reason for Recall
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Initiated
05-17-2016
Reported
09-07-2016
Quantity
1,771,244 bottles for all shades

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74746
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Clinique International
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-14-2018
Product Description About Product Description
Full technical description of the 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. 20714-48241-1, Shade 06 (D-G)

Batch or Lot Expiration Information

Lot# all lots

Recall Number: D-1475-2016

Reason for Recall
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Initiated
05-17-2016
Reported
09-07-2016
Quantity
1,771,244 bottles for all shades

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74746
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Clinique International
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-14-2018
Product Description About Product Description
Full technical description of the 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)

Batch or Lot Expiration Information

Lot# all lots

Recall Number: D-1474-2016

Reason for Recall
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Initiated
05-17-2016
Reported
09-07-2016
Quantity
1,771,244 bottles for all shades

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74746
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Clinique International
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-14-2018
Product Description About Product Description
Full technical description of the 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. 20714-47477-5, Shade 02 (VF-N)

Batch or Lot Expiration Information

Lot# all lots

Recall Number: D-1476-2016

Reason for Recall
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Initiated
05-17-2016
Reported
09-07-2016
Quantity
1,771,244 bottles for all shades

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74746
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Clinique International
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-14-2018
Product Description About Product Description
Full technical description of the 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. 20714-47479-9, Shade 04 (M-N)

Batch or Lot Expiration Information

Lot# all lots

Recall Number: D-1473-2016

Reason for Recall
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Initiated
05-17-2016
Reported
09-07-2016
Quantity
1,771,244 bottles for all shades

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74746
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Clinique International
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-14-2018
Product Description About Product Description
Full technical description of the 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)

Batch or Lot Expiration Information

Lot# all lots

Recall Number: D-1477-2016

Reason for Recall
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Initiated
05-17-2016
Reported
09-07-2016
Quantity
1,771,244 bottles for all shades

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74746
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Clinique International
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-14-2018
Product Description About Product Description
Full technical description of the 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. 20714-48240-4, Shade 05 (D-G)

Batch or Lot Expiration Information

Lot# all lots