Recalls / Class III
Class IIID-1267-2020
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
- Brand name
- Chapstick Total Hydration Moisture Tint Very Berry
- Generic name
- Zinc Oxide
- Active ingredient
- Zinc Oxide
- Route
- Topical
- NDC
- 0573-0872
- FDA application
- M016
- Affected lot / code info
- Lot #: 9346AA, 9347AA
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
- 288 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-1267-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.