Once again, Johnson & Johnson is suffering a quality control problem leading to a product recall. This time, the health care giant has recalled approximately 70,000 pre-filled syringes for its Invega Sustenna injectable antipsychotic in the US, while still more were yanked from other countries. The reason: a crack in the syringe barrel covered by labeling, which makes it hard to detect.
A spokesman for Johnson & Johnson's Janssen unit, which markets the med, says four lots were recalled from overseas, but was unable to say exactly how many syringes were involved. He maintained, however, that no adverse events were reported. We will update you with any further info we receive.
"Theoretically, a crack in the syringe barrel could compromise the sterility of the syringe contents and possibly result in local injection site reactions such as injection site infections, or systemic infections," according to this recall notice. "Theoretically, leakage of the injection suspension through the crack could result in a lower than intended therapeutic dose." The recall only pertains to the 234 mg dosage, by the way.
Normally, such recalls attract little attention, but Johnson & Johnson has suffered a remarkable string of such mishaps for more than a year involving a wide range of products - over-the-counter pediatric meds, including Tylenol, Rolaids, Sudafed and Benadryl; hip replacement devices, contact lenses.
The recalls, however, were not all run-of-the-mil episodes. A congressional investigation revealed that Johnson & Johnson surreptitiously conducted a recall of some OTC products after discovering problems at its plants and hired outside contracts to work as 'mystery shoppers.' The FDA, meanwhile, has issued dozens of inspection reports, inspectional observation reports and warning letters (see here).
The incidents have hurt Johnson & Johnson in myriad ways - sales are down and forecast to remain lower than previously expected; a plant has been shuttered and undergoing retooling; at least 300 jobs have been lost; employee bonuses have been cut; consumer trust has been undermined; one Wall Street analyst looks for the FDA to issue a consent decree, and federal and state probes are under way.
The chain of events have led some to call for ceo Bill Weldon to resign amid criticism of the board. So far, though, Bill and the board have not been subject to the same kind of recalls as so many Johnson & Johnson products and employees.