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Recall Observatory FDA recall evidence

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

May 28, 2024

Class II

Product summary

Firm
Consumer Product Partners, LLC
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

    reason.labeling_packaging · v1.0.0

    Labeling: Label Mix up