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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
_______________________________________________
FORM 8-K
______________________________________________
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
August 6, 2024
_______________________________________________
Perrigo Company plc
(Exact name of registrant as specified in its charter)
_______________________________________________
Commission file number 001-36353
| | | | | | | | |
| Ireland | | Not Applicable |
(State or other jurisdiction of incorporation or organization) | | (I.R.S. Employer Identification No.) |
The Sharp Building, Hogan Place, Dublin 2, Ireland D02 TY74
+353 1 7094000
(Address, including zip code, and telephone number, including
area code, of registrant’s principal executive offices)
Not Applicable
(Former name or former address, if changed since last report)
________________________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ Written communications pursuant to Rule 425 under the Securities Act
(17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act
(17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act
(17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act
(17 CFR 240.13e-4(c))
Securities Registered pursuant to section 12(b) of the Act:
| | | | | | | | |
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| | |
| Ordinary shares, €0.001 par value | PRGO | New York Stock Exchange |
| 3.900% Notes due 2024 | PRGO24 | New York Stock Exchange |
| 4.375% Notes due 2026 | PRGO26 | New York Stock Exchange |
4.900% Notes due 2030 | PRGO30 | New York Stock Exchange |
| 5.300% Notes due 2043 | PRGO43 | New York Stock Exchange |
| 4.900% Notes due 2044 | PRGO44 | New York Stock Exchange |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
ITEM 7.01 Regulation FD Disclosure
On August 6, 2024, Perrigo Company plc (“Perrigo” or the “Company”) initiated a voluntary recall at the retailer and warehouse level of three lots within one batch, or 16,500 cans, of store brand Premium Infant Formula with Iron Milk-Based Powder sold at H-E-B Grocery Company and CVS. The product being recalled shipped to CVS between February 6-11, 2024, and to H-E-B between February 2, 2024 – May 13, 2024. No other products or retailers are impacted by this recall.
The financial cost associated with this recall is not expected to be material and has no impact on the Fiscal Year 2024 Outlook provided by Perrigo on August 2, 2024.
On August 8, 2024, the Company issued a press release with additional information about the voluntary recall. The press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
The information in this Item 7.01, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, nor shall it be deemed incorporated by reference in any Company filing under the Securities Act of 1933 or the Securities Exchange Act of 1934, except as may be expressly set forth by specific reference in such filing.
Forward-Looking Statements
This Current Report on Form 8-K includes certain “forward-looking statements” within the meaning of the Private Litigation Securities Reform Act of 1995, as amended. Forward-looking statements relate to future events, including the expected financial impact and costs of the recall, and involve known and unknown risks, uncertainties and other factors — many of which beyond the Company’s control — that may cause the actual results, performance or achievements of the Company to be materially different from its current expectations, assumptions, estimates and projections. Interested persons are urged to consult the Company’s filings with the United States Securities and Exchange Commission, available at https://investor.perrigo.com/sec-filings, for a discussion of the Company’s business and financial condition and certain material trends, risks, uncertainties and other factors relating thereto, including those discussed under “Risk Factors” in the Company’s Form 10-K for the year ended December 31, 2023.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| | | | | | | | |
| | |
| Exhibit Number | | Description |
| |
99.1 | | |
104 | | Cover Page Interactive Data file (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| | | | | | | | | | | | | | |
| | | (Registrant)
|
| | | PERRIGO COMPANY PLC
|
| | | | |
| | | By: | /s/ Todd W. Kingma |
| Dated: | August 8, 2024 | | | Todd W. Kingma |
| | | | Executive Vice President, General Counsel and Secretary |
| | | | |
| | | | |
perrigoinfantformulareca
1 Perrigo Issues Voluntary Recall of One Batch of Premium Infant Formula with Iron Milk- Based Powder Due to Elevated Levels of Vitamin D Perrigo Consumer Affairs Contact Information: 1-800-538-9543 Dublin, Ireland and Allegan, MI – August 8, 2024 – Perrigo Company plc is issuing a voluntary recall at the retailer and warehouse level of three lots within one batch, or 16,500 cans, of store brand Premium Infant Formula with Iron Milk-Based Powder due to levels of Vitamin D above the maximum level permitted. The recalled product was shipped to H-E-B Grocery Company, LP in TX ; and CVS in the following states: TX, FL, CA, SC, VA, IN, TN, NJ, MI, PA, RI, MO. No other products or retailers are impacted by this recall. The Company is initiating this voluntary recall in consultation with the U.S. Food and Drug Administration (FDA). There have been no reports of adverse events to date attributed to the elevated levels of Vitamin D in the product subject to this recall, which was determined through routine testing. For the vast majority of infants, short-term consumption of the affected lot codes is unlikely to cause adverse health implications. In a small subset of physiologically vulnerable infants (e.g., impaired renal function), there is the potential that consumption of the recalled product could result in health complications. Parents and caregivers who may have purchased the product should look for the lot codes below with “use by” dates, which can be found on the bottom of the package and should contact their health care provider if they have any concerns. Perrigo has taken immediate action by notifying H-E-B Grocery Company, LP and CVS directly and asking them to examine their retail and warehouse inventory and isolate the product. Product shipped to CVS beginning February 6, 2024, being recalled: T11LMYC – USE BY 11NOV2025 (Material: 975261, UPC: 050428318034) Product shipped to H-E-B Grocery Company, LP beginning February 2, 2024, being recalled: T11LMXC – USE BY 11NOV2025 T09LMXC – USE BY 09NOV2025 (Material: 788362, UPC: 041220164578)
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4 No other lot codes are impacted by this recall. If infants experience any symptoms while using the product, report them to the FDA's MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm. Additionally, please contact your healthcare provider. Any questions or concerns regarding the recall or adverse events associated with these lot codes can be communicated to Perrigo Consumer Affairs at 1-800-538-9543, M-F from 8:00am-5:00pm EST.