Drug product
Petroleum Jelly, White Petrolatum USP, NET WT 13 OZ (368g), sold under the following brands - Rite Aid, with UPC 0-11822-51349-4; Kroger, with UPC 0-41260-35275-1; Harris Teeter, with UPC 0-72036-75051-8; CVS, with UPC 0-50428-31702-0
D-0560-2024
Product summary
- Event
- Event 94710
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1015 cases
- Official record key
drug-enforcement:D-0560-2024
Official wording
Reason: Labeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum jelly with Lavendar and Chamomile
Code information: Rite Aid - lot # 0607983, expiration date: 07/2026, NDC # 11822-3135-2 Kroger- lot # 0607983, expiration date: 07/2026, NDC# 30142-069-27 Harris Teeter - lot # 0607983, expiration date: 07/2026, NDC# 72036-069-27 CVS- lot # 0607983, expiration date: 07/2026, NDC # 59779-069-27
Distribution pattern: Nationwide.
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix up