Recall Enforment Report D-0560-2024

Recall Details

Drug Recall Enforcement Report Class II voluntary initiated by Consumer Product Partners, LLC, originally initiated on 05-28-2024 for the 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 The product was recalled due to labeling: label mix up; product labeled as pure white petroleum jelly actually contains petroleum jelly with lavendar and chamomile. The product was distributed nationwide and the recall is currently ongoing.

Field Name Field Value
Event ID 94710 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number D-0560-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern Nationwide. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description 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
Reason For Recall Labeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum jelly with Lavendar and Chamomile What is the Reason for Recall?
Information describing how the product is defective.
Product Quantity 1015 cases Product Quantity
The amount of product subject to recall.
Voluntary Mandated Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date 06-26-2024
Recall Initiation Date 05-28-2024 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type Drugs
Recalling Firm Consumer Product Partners, LLC
Code Info 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 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages 11822-3135-4; 11822-3135-2; 30142-069-07; 30142-069-27; 30142-069-54; 72036-069-27; 72036-069-54; 59779-069-27; 59779-069-54; 59779-069-18; 59779-069-96
Status Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
11822-3135Pure Petroleum White PetrolatumJellyTopicalRite AidHuman Otc Drug
30142-069Petroleum White PetrolatumJellyTopicalKroger CoHuman Otc Drug
59779-069Petroleum White PetrolatumJellyTopicalCvs PharmacyHuman Otc Drug
72036-069Petroleum White PetrolatumJellyTopicalHarris TeeterHuman Otc Drug