FDA Drug Recalls

Recalls / Class III

Class IIID-1268-2020

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

Brand name
Chapstick Total Hydration Moisture Tint Pretty In Pink
Generic name
Zinc Oxide
Active ingredient
Zinc Oxide
Route
Topical
NDC
0573-0873
FDA application
M016
Affected lot / code info
Lot #: 9343AA, 9343BA

Why it was recalled

Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card

Recalling firm

Firm
Glaxosmithkline Consumer Healthcare Holdings
Manufacturer
Haleon US Holdings LLC
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
184 Liberty Corner Rd, N/A, Warren, New Jersey 07059-6796

Distribution

Quantity
360 packages
Distribution pattern
Nationwide

Timeline

Recall initiated
2020-04-20
FDA classified
2020-05-13
Posted by FDA
2020-05-20
Terminated
2021-10-26
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1268-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class III recall: Chapstick Total Hydration Moisture Tint Pretty In Pink · FDA Drug Recalls