FDA warning letter tops off J&J recall news

More manufacturing-related woes for Johnson & Johnson. On top of yesterday's insulin-cartridge recall, the company got an FDA warning letter on a stent-making plant in Puerto Rico.

First, the recall: J&J released more information late yesterday about adverse events associated with the potentially leaky insulin cartridges. Some 22 people have experienced side effects, but none of those reactions was serious enough to require hospitalization, Reuters reports. More than 380,000 of the cartridges made by J&J's Animas unit were recalled.

Separately, the FDA has warned J&J's Cordis unit that its plant in San German, Puerto Rico, failed to ensure that heart devices manufactured there were properly made. Inspectors said the plant's procedures couldn't ensure that the devices met specifications; in fact, they said the company had shipped stents that did not completely expand.

As the Star-Ledger reports, the FDA said in its letter the issues cited "may be symptomatic of serious problems." A Cordis spokeswoman told Bloomberg the unit is "working to address the questions raised" and that the company is "confident our product remains safe and effective."

- read the Star-Ledger piece
- get more from Reuters
- see the Bloomberg coverage

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