The regulator has already issued more recalls in the first half of 2014 than it has over the past nine years.
The new rules are expected to do away with the haphazard nature of facility inspections.
It's the generics maker's second recall of 2014.
The drugmaker is pulling its US marketing application for the anemia drug.
The US-only recall amounts to less than 1% of the company's inventory.
The company beat consensus estimates, with particular sales strengths from its pharmaceuticals division.
1,100 workers will lose their jobs at a plant with a history of around 40 recalls.
GSK and Astellas kick off the race for a new anemia treatment; Orexigen's CEO joins PhRMA; BMS and Merck team up in a hep.-C clinical trial; Novartis lands glaucoma approval; Ireland starts naming preferred drugs; Novo has new New Jersey digs; Vertex releases promising data for new cystic fibrosis treatment.
A buyout offer upsets Elan's post-Tysabri plans, Takeda and Affymax recall Omontys.
CEO Alex Gorsky said OTC brands are coming back. Meanwhile, pharmaceutical sales provided ballast to the year's numbers.
J&J is pushing back hard against a Wall Street Journal article suggesting that a pair of retirements and a promotion are part of a corporate shakeup of its recall-plagued McNeil Consumer Healthcare division.