Cracks in syringes prompted Johnson & Johnson to recall 70,000 doses of its long-lasting antipsychotic drug Invega Sustenna. Produced by the J&J prescription drugs unit Janssen, rather than the recently-recall-prone McNeil Consumer Healthcare, the cracked syringes are nonetheless a new signal of manufacturing quality problems.
Some prefilled syringes were found to have cracks that users couldn't detect because they were covered by labels. Spokesman Greg Panico told Dow Jones that the cracks might have been caused by stress applied when the labels were attached. The cracks were found during routine testing. "Our manufacturing team did resolve the issue and the production line is up," Panico told the news service.
The problem with the cracks is that pathogens might contaminate the drug and cause infection, and that a lower-than-normal dose might result if the drug leaked out. Janssen said in a notice on its website that it has received no reports of infections, nor has it heard of any leakages. Panico, however, said that J&J got an adverse-event report from Australia that may be related to the cracks.
If you've been following J&J's recent travails, you know that this is the latest in a series of recalls affecting products made in the U.S. and Puerto Rico, including such big names as Tylenol, Motrin and Rolaids. Most of the recalls have involved consumer drugs, but J&J's device division recalled some joint-replacement parts, and its eye-care division recalled contact lenses.
The company has shuffled its quality control management, shuttered one plant for retooling and retraining, and stepped up internal inspections in an attempt to curtail the problems.
- see the Janssen recall notice
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