- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Reason for Announcement:
Recall Reason Description
Presence of asbestos
- Company Name:
- Johnson & Johnson Consumer Inc.
- Brand Name:
- Product Description:
Out of an abundance of caution, Johnson & Johnson Consumer Inc. (JJCI) announced that it is initiating a voluntary recall in the United States of a single lot of its Johnson’s Baby Powder in response to a U.S. Food and Drug Administration (FDA) test indicating the presence of sub-trace levels of chrysotile asbestos contamination (no greater than 0.00002%) in samples from a single bottle purchased from an online retailer. Despite the low levels reported and in full cooperation and collaboration with the FDA, JJCI is initiating this voluntary recall of Lot #22318RB of Johnson’s Baby Powder, from which the tested sample was taken.
In parallel, JJCI has immediately initiated a rigorous, thorough investigation into this matter, and is working with the FDA to determine the integrity of the tested sample, and the validity of the test results. At this early stage of the investigation, JJCI:
- Cannot confirm if cross-contamination of the sample caused a false positive.
- Cannot confirm whether the sample was taken from a bottle with an intact seal or whether the sample was prepared in a controlled environment.
- Cannot confirm whether the tested product is authentic or counterfeit.
JJCI has a rigorous testing standard in place to ensure its cosmetic talc is safe and years of testing, including the FDA’s own testing on prior occasions–and as recently as last month–found no asbestos. Thousands of tests over the past 40 years repeatedly confirm that our consumer talc products do not contain asbestos. Our talc comes from ore sources confirmed to meet our stringent specifications that exceed industry standards. Not only do we and our suppliers routinely test to ensure our talc does not contain asbestos, our talc has also been tested and confirmed to be asbestos-free by a range of independent laboratories, universities and global health authorities.
For 133 years, the Johnson & Johnson Family of Companies have been committed to putting the needs and well-being of the people we serve first, and we will continue to do so.
If you or someone you provide care for owns a bottle of Johnson’s Baby Powder Lot #22318RB, you are advised to discontinue use of the product. For refund information, contact the Johnson & Johnson Consumer Care Center at www.johnsonsbaby.com or by calling +1 (866) 565-2229.
NOTE TO INVESTORS CONCERNING FORWARD-LOOKING STATEMENTS:
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the voluntary recall of one lot of Johnson’s Baby Powder. The reader is cautioned not to rely on these forward-looking statements. The forward-looking statements in this press release are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections Johnson & Johnson Consumer Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: product efficacy or safety concerns resulting in product recalls or regulatory action; significant adverse litigation or government action, including related to product liability claims; uncertainty of commercial success for new and existing products; the ability of the company to successfully execute strategic plans; manufacturing difficulties or delays, internally or within the supply chain; changes to applicable laws and regulations; changes in behavior and spending patterns of purchasers of health care products and services; and increased scrutiny of the health care industry by government agencies. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 30, 2018, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” in the company’s most recently filed Quarterly Report on Form 10-Q and in the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Any forward-looking statement made in this release speaks only as of the date of this release. Neither Johnson & Johnson Consumer Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. The Company expressly disclaims all liability in respect to actions taken or not taken based on any or all the contents of this press release.
(917) 697-2318 (M)
Company Contact Information
- Ernie Knewitz
- (732) 524-6623, (917) 697-2318 (M)
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