Food and Drug Administration staff is still investigating Friday’s recall of some of Johnson & Johnson’s Tylenol children’s products, but have not ruled out taking further action, an agency spokeswoman said on Monday .
Friday’s recall of more than 40 widely used nonprescription products for children and infants such as Tylenol, Motrin, Zyrtec and Benadryl affects at least 1,500 product lots, FDA spokeswoman Elaine Bobo also told Reuters, adding it is unclear how many actual bottles are affected.
She said it is too early to tell if the agency will take further action against Johnson & Johnson and the FDA is still gathering information in the Tylenol case.
The FDA asked Johnson & Johnson to recall products on Friday following a routine inspection of its Fort Washington, Pennsylvania, facility April 19-30, Bobo said. The drugmaker issued the recall late Friday night.
“Our thought was because these over-the-counter products are so widely used and because it hit such vulnerable populations with infants and children, that we really needed to get the word out there to at least give consumers a heads’ up before we had all the specifics,” Bobo said.
The FDA said on Friday the company was implementing the voluntary recall due to manufacturing deficiencies that might affect quality, purity or potency.
Despite the recall, Johnson & Johnson shares closed up 1.6 percent, or $1.03, to $65.33 on Monday, roughly in line with the market overall.
Sanford Bernstein analyst Derrick Sung said that, while the recall was “yet another hit” to the reputation of Johnson & Johnson’s consumer business, “the impact of that alone on the overall company is still relatively minor.”
Johnson & Johnson, with $61.9 billion in sales last year, sells a wide array of prescription drugs, medical devices and consumer products.
While investors appeared to shrug off the recall on Monday, “if they don’t handle it well, I think it’s a bigger concern later on,” said Noble Financial Group analyst Jan Wald.
If it “looks like it’s hiding something or isn’t fully disclosing … I think that’s where it can get hurt,” Wald said.
Depending on the strength of J&J’s response to the recall, a senior industry compliance consultant said there is a 50/50 chance the drugmaker could face a consent decree — a court enforced agreement between the FDA and the company.
“These days, FDA is very aggressive,” the consultant said. “With limited resources, they have very little patience with firms making promises. They just go right into heavier regulatory type enforcement actions to get companies to move quickly.”
All of the seven categories of products affected by the recall were made at the Fort Washington plant where manufacturing has been halted, Johnson & Johnson spokeswoman Caroline Almeida said, adding the drugs were not being made anywhere else in the meantime.
Asked about possible supply constraints, Almeida said the company was advising consumers to contact pharmacists and healthcare providers to suggest alternative options.
She did not have a specific timetable for when production might begin again, saying corrective actions would need to be implemented first. J&J said it was “conducting a comprehensive quality assessment across its manufacturing operations.”
Consumers can find more information at www.mcneilproductrecall.com
Source: Reuters
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