Perrigo Issues Voluntary Recall of Infant Formula Due to Elevated Vitamin D Levels

Perrigo Issues Voluntary Recall of Infant Formula Due to Elevated Vitamin D Levels

Perrigo Issues Voluntary Recall of Infant Formula | Healthcare 360 Magazine

(Source-wrnjradio.com)

Dublin, Ireland and Allegan, MI – August 8, 2024 – Perrigo Issues Company plc has announced a voluntary recall of a specific batch of its store brand Premium Infant Formula with Iron Milk-Based Powder due to concerns over elevated levels of Vitamin D. The recall affects three specific lots within one batch, amounting to 16,500 cans of the product. These were distributed to H-E-B Grocery Company, LP in Texas and CVS locations across several states, including Texas, Florida, California, South Carolina, Virginia, Indiana, Tennessee, New Jersey, Michigan, Pennsylvania, Rhode Island, and Missouri.

This recall is limited to the aforementioned locations, and no other products or retailers are involved. Perrigo issues is working in close consultation with the U.S. Food and Drug Administration (FDA) to manage this situation and ensure consumer safety.

Reason for the Recall

The decision to issue the recall came after routine testing revealed that the levels of Vitamin D in the affected product exceeded the maximum levels permitted by regulatory guidelines. While no adverse health events have been reported to date, Perrigo issues is acting proactively to prevent any potential health risks, particularly for infants who may be more vulnerable to such variations.

For most infants, short-term consumption of the affected formula is unlikely to result in serious health issues. However, there is a concern for a small subset of infants, especially those with pre-existing conditions such as impaired renal function. These infants may be at risk of health complications if they consume the recalled formula. Parents and caregivers are urged to check the lot codes on the product packaging and consult their healthcare providers if they have any concerns.

Details of the Recalled Product

The specific lot codes of the recalled product, along with their corresponding “use by” dates and other identifying information, are as follows:

CVS (Shipped beginning February 6, 2024):

Lot Code: T11LMYC – USE BY 11NOV2025

Material: 975261, UPC: 050428318034

H-E-B Grocery Company, LP (Shipped beginning February 2, 2024):

Lot Code: T11LMXC – USE BY 11NOV2025

Lot Code: T09LMXC – USE BY 09NOV2025

Material: 788362, UPC: 041220164578

Consumers are advised to locate the lot code and “use by” date on the bottom of the package. If the product matches any of the recalled lot codes, it should not be used, and the retailer should be contacted for further instructions.

Actions Taken by Perrigo Issues

Upon discovering the elevated Vitamin D levels, Perrigo immediately notified the affected retailers, H-E-B Grocery Company, LP, and CVS, instructing them to examine their retail and warehouse inventories. The company has requested that any remaining products from the recalled lots be isolated to prevent further distribution.

Perrigo is also providing support to parents and caregivers who may have purchased the recalled formula. Any questions or concerns about the recall, or reports of adverse events, can be directed to Perrigo issues Consumer Affairs at 1-800-538-9543 during business hours (Monday to Friday, 8:00 AM – 5:00 PM EST).

Reporting and Further Guidance

Parents and caregivers who suspect that their infants have experienced any symptoms related to the use of the recalled formula are encouraged to report these incidents to the FDA’s MedWatch Adverse Event Reporting program. The FDA’s reporting portal can be accessed online at www.fda.gov/medwatch/report.htm.

Perrigo issues remains committed to consumer safety and is taking all necessary measures to address this issue swiftly. The company reassures the public that no other lot codes or products are impacted by this recall, and it will continue to work with the FDA to monitor the situation closely.

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