Multi-event April 2020 FDA Recall Chapstick Total Hydration Moisture Tint Peachy Keen by Glaxosmithkline Consumer Healthcare Holdings

This Multi-event Class III drug recall was voluntarily initiated by Glaxosmithkline Consumer Healthcare Holdings on April 20, 2020 for the product Chapstick Total Hydration Moisture Tint Peachy Keen. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1266-2020 TERMINATED D-1267-2020 TERMINATED D-1268-2020 TERMINATED

Recall Number: D-1266-2020

Reason for Recall
Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
Initiated
04-20-2020
Reported
05-20-2020
Quantity
288 packages

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85500
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.
Glaxosmithkline Consumer Healthcare Holdings
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-26-2021
Product Description About Product Description
Full technical description of the product.
ChapStick Total Hydration Moisture + Tint + SPF15 Peachy Keen Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA, NDC 0573-0871-08

Batch or Lot Expiration Information

Lot# : 9344AA, 9345AA

Affected Packages Involved in this Recall

0573-0871-08 Chapstick Total Hydration Moisture Tint Peachy Keen
0573-0871-11 Chapstick Total Hydration Moisture Tint Peachy Keen

Recall Number: D-1267-2020

Reason for Recall
Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
Initiated
04-20-2020
Reported
05-20-2020
Quantity
288 packages

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85500
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.
Glaxosmithkline Consumer Healthcare Holdings
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-26-2021
Product Description About Product Description
Full technical description of the product.
ChapStick Total Hydration Moisture + Tint + SPF15 Very Berry Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA NDC 0573-0872-08

Batch or Lot Expiration Information

Lot# : 9346AA, 9347AA

Affected Packages Involved in this Recall

0573-0872-08 Chapstick Total Hydration Moisture Tint Very Berry
0573-0872-11 Chapstick Total Hydration Moisture Tint Very Berry

Recall Number: D-1268-2020

Reason for Recall
Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
Initiated
04-20-2020
Reported
05-20-2020
Quantity
360 packages

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85500
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.
Glaxosmithkline Consumer Healthcare Holdings
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-26-2021
Product Description About Product Description
Full technical description of the product.
ChapStick Total Hydration Moisture + Tint + SPF15 Pretty in Pink Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA NDC 0573-0873-08

Batch or Lot Expiration Information

Lot# : 9343AA, 9343BA

Affected Packages Involved in this Recall

0573-0873-08 Chapstick Total Hydration Moisture Tint Pretty In Pink
0573-0873-11 Chapstick Total Hydration Moisture Tint Pretty In Pink