In a move reminiscent of the Tylenol scare of the 1980s,Perrigo on Thursday recalled 11 million bottles of store-brand acetaminophen caplets. There were traces of metal in some of the products, according to the U.S.U.S. Food and Drug Administration (FDA).
Perrigo is voluntarily recalling 383 lots of the 500 mg acetaminophen caplets that it sells as generics for private store labels. Acetaminophen is the active ingredient in Tylenol and similar brands.
“Based on information currently available, the FDA believes the probability of serious adverse health consequences is remote; however, if a consumer were to swallow an affected caplet, it could result in minor stomach discomfort and/or possible cuts to the mouth or throat. Consumers should consult their physician if they suspect they’ve been harmed by use of this product,” the agency said in a statement.
Currently, both Perrigo and the FDA are investigating the problem. The company informed the FDA of the issue after discovering, via its own regulatory quality control procedures, that its tableting equipment was wearing down prematurely.
Perrigo reported a test of 70 million caplets with a metal detector resulted in the discovery of approximately 200 caplets containing metal fragments ranging in size from microdots to portions of wire 8 mm in length.
The recall is not expected to cause a shortage of acetaminophen, said the FDA. Only the Perrigo 500 mg strength caplets are affected.
Johnson & Johnson’s market share declined dramatically in 1982, when several people died after ingesting Tylenol laced with cyanide. In the case of the Perrigo recall, though, there is no foul play involved. No injuries or illnesses have been reported, according to the FDA.
Due to the publicity surrounding the recall, Perrigo shares fell nearly 4 percent to US$17.32 on the Nasdaq. The world’s largest manufacturer of generic pharmaceutical and nutritional products, Perrigo estimates the cost of the recall could go as high as $2.9 million. The company did not return calls seeking comment.
Crisis Communications 101
Retailers that sell the drugs — including CVS, Kroger and Wal-Mart — must be prepared to deal with customer concerns about the tainted acetaminophen caplets, according to Todd Templin, vice president of Boardroom Communications. Templin specializes in crisis communications.
“The retailers that carry the product need to emphasize two things of importance to their customers: that all of the bad product is removed, and the chance of major illness or injury is very slight,” he told TechNewsWorld.
Other companies can learn from this type of event. A crisis is not just bad news, said Vince McMorrow, vice president of public relations for RMD Advertising. “Every brand will face bad news. A crisis is when something occurs that keeps you from handling your regular business in a normal fashion,” he said. “A crisis is an event that has the potential to cause great harm to your organization.”
Consumers can determine whether they are in possession of a recalled product by locating the batch number printed on the container label. Alist of stores that could be affected by this recall is posted on the FDA’s Web site. Perrigo is notifying its distributors and retailers regarding how to facilitate product replacement.
Consumers who believe they own the affected products should discontinue their use immediately and call Perrigo’s consumer affairs department at 877-546-0454.