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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Notification of Stolen Bayer Healthcare Aleve® Liquid Gels and Caplets Product (Ontario, California)

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Date Posted: 5/31/2013

 

Bayer HealthCare’s Consumer Care division is working with the U.S. Food and Drug Administration (FDA), Office of Criminal Investigation (OCI), and other law enforcement officials to recover stolen portions of two lots of non-prescription Aleve® Liquid Gels and Aleve® Caplets intended for retail sale.  The product was contained in a trailer awaiting delivery of its contents to a single store in Mira Loma, California at the time of the theft in Ontario, California on May 27, 2013. Impacted lots are listed in Table 1 below.

 

Aleve® products are safe and effective when used as directed and purchased from legitimate and reputable retail outlets and pharmacies.  Bayer HealthCare recommends that consumers always inspect the product and label for signs of tampering before opening.  Aleve® products are packaged in "tamper-evident" containers, meaning that if the package has been opened, it will be evident to the consumers. In addition, consumers and retailers should report any evidence of suspected product tampering to our toll-free number (800-395-0689, M-F, 9AM – 5PM EST).

 

Bayer advises consumers and retailers to always purchase product only from trusted and reliable sources.  For consumer inquiries about a specific product, please call the toll-free number (800-395-0689, M-F, 9AM – 5PM EST) identified on the package.

 

Anyone who has information regarding this incident, or has received suspicious or unsolicited offers for the specified Aleve® products after the date of the theft, is encouraged to contact the U.S. Food and Drug Administration (FDA) Office of Criminal Investigations at 1-800-551-3989 or to visit the OCI Web Site (http://www.fda.gov/OCI).

 

 

Below is the list of affected products, including Item number, Description/Size, Lot Code and Lot expiration. These products represent only a portion of each product lot.

 

TABLE 1

 

 

Item Number

Description / Size

Lot Code

Lot Expiration

80659289

Aleve Liquid Gels 160ct

NAA192K

12/31/2014

80817592

Aleve Club Tray Pack 320ct (Caplets)

NAA198L

8/31/2015

 

 

 

Bayer has taken appropriate actions to ensure the safety of its products and will continue to work closely with law enforcement, the FDA, and distribution partners to maintain the integrity of the supply chain.