ALLEGAN, Mich. — Over 100 retailers and wholesalers, more than 25 of which are supermarkets, were affected by the massive recall of store-brand acetaminophen earlier this month.
The voluntary recall initiated by generic over-the-counter drug manufacturer Perrigo Co. here asked stores to pull about 11 million bottles of 500-milligram caplets off shelves. Acetaminophen is the generic equivalent of Tylenol, which is made by McNeil Consumer Healthcare, Fort Washington, Pa.
Although the recall is officially a retail-level initiative, Perrigo added a consumer component to its hotline and website after the Food and Drug Administration released a recall announcement listing the lot numbers, which “got more consumers involved,” said Perrigo spokesman Ernie Schenk.
“That is when we opened up our consumer hotline because we were getting questions,” he said.
In its instructions to consumers, Perrigo says nothing about returning the product to stores; instead, it seeks to engage purchasers directly. The website says to either “discard the package” or return it by mail. An outgoing message on a toll-free phone line advises consumers to leave their name and address, and then wait for a “return kit” to be sent.
Perrigo's reason for dealing directly was to alleviate the burden on retailers, Schenk added.
Nonetheless, retailers are taking back the recalled acetaminophen.
Food Lion, Salisbury, N.C., is accepting returns on the product, where it is sold under the Food Lion brand, “as we do with most products,” spokesman Jeff Lowrance told SN.
Supervalu, Eden Prairie, Minn., said the same, as did Publix Super Markets, Lakeland Fla.
“Whether a recall is industrywide or Publix-specific, we always refund or exchange the product,” Publix spokeswoman Maria Brous told SN.
None of the retailers SN spoke to were aware of how or if they would be reimbursed for product returns.
“We know that Perrigo is still working on how to handle the cost, but we don't know what will take place between the retail purchasers and the suppliers,” Brous said.
“I can't conceive of a major manufacturer-fault recall not allowing a return of the affected merchandise for full credit,” said Bruce Kneeland, president, Pharmacy Connections, Valley Forge, Pa.
Schenk told SN that Perrigo will reimburse retailers for all affected product including that returned directly to stores by consumers. According to Perrigo's view of the situation, “the [recalled] product is typically returned to Perrigo with the other stock removed from the shelves or warehouses.”
While it is too early to gauge the recall's full impact on the category, removing bottles of store-brand acetaminophen from shelves did require extra time and labor, Lowrance said.
Even Buehler's Markets, Wooster, Ohio, which was unaffected by the recall, is prepared for customer questions, said Verne Mounts, director of pharmacy.
Wal-Mart Stores, which sells the pills under its Equate store brand, blocked the sale of the product at its registers and pulled it off shelves. “We don't know if it will affect sales of related products but right now customer safety is our top priority,” spokeswoman Jami Arms told SN.
After speaking to an unaffected generic drug distributor that provides private-label acetaminophen to a number of supermarkets, Kneeland noted, “they made quick motions to get information, in the form of signs and electronic shelf talkers, out to the stores to let customers know that their product is OK.”
The information is meant to keep customers from adopting a negative view of all store-brand products, Kneeland said. “I don't think the typical consumer will bother checking whether it's 500-milligram or 325-milligram acetaminophen, or whether it's capsules as opposed to caplets, or if its even the ibuprofen version of the store brand or the Robitussin.”
Tylenol, however, represents an example of why this recall might not hurt store-brand sales, according to Paul Simon, spokesman, Schnuck Markets, St. Louis.
“Tylenol has had major recalls before, so people understand that is going to happen,” Simon noted.
Part of that history was the 1982 tampering case that resulted in the death of seven people in the Chicago area, and major changes in over-the-counter drug packaging. The brand eventually regained its popularity and sales. Tylenol's website now displays a prominent statement that it does not make store-brand acetaminophen.
Schnucks heavily promotes its store brands, including its Schnucks brand and its other private-label brand, Topcare, Simon said. “We haven't heard any consumer problems with the affected Topcare brand and we will continue to promote those items.”
Topco, Skokie, Ill., which distributes the Topcare line, declined to comment on the recall.
Although at press time no consumer complaints related to the pills had been reported to the FDA, Perrigo's quality control system had identified traces of a metal particulate in about one in every 400,000 cap-lets, triggering the recall.