Petroleum Jelly, White Petrolatum USP, NET WT 13 OZ (368g), sold under the following brands - Rite Aid, with UPC 0-11822
Summary
The FDA issued a Class II for Petroleum Jelly, White Petrolatum USP, NET WT 13 OZ (368g), sold under the follo by Consumer Product Partners, LLC. Reason: Labeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum jelly with Lavendar and Chamomile.
Details
Source
Drug Recall
External ID
D-0560-2024
Action Date
2024-06-26
Status
Terminated
Category
drug
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
Lot/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
Quantity Affected: 1015 cases
Reason for Recall
Labeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum jelly with Lavendar and Chamomile
Distribution
Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-28
Company
Smyrna, TN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 33 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Consumer Product Partners, LLC has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Consumer Product Partners, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Consumer Product Partners, LLC have FDA actions?
Consumer Product Partners, LLC has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0560-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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