FDA recall record

OraLabs Petroleum jelly (White Petrolatum) USP 100% recall — FDA D-0624-2020

Cross contamination with other products: undeclared contaminants of phenol and camphor in petroleum jelly tubes.

Class IIclassification
D-0624-2020official record ID
Dec 18, 2019report date

Recall record at a glance

Official recordD-0624-2020
CategoryDrug Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmOraLabs, Inc.
Report dateDec 18, 2019
Recall initiation dateNov 25, 2019
QuantityN/A
LocationParker, CO, United States

Official product description

Petroleum jelly (White Petrolatum) USP 100%, packaged in a) 1 oz tube (UPC 1182298884), b) 2.5 oz tube (UPC 1182298541), Distributed by Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011

Why the product was recalled

Cross contamination with other products: undeclared contaminants of phenol and camphor in petroleum jelly tubes.

Distribution information

Nationwide within the United States

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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