Johnson & Johnson Factory Cited For Quality Lapses

So what sorts of problems led Johnson & Johnson to recall a slew of kids' medicines, including several kinds of Motrin and Tylenol, made in a factory outside Philadelphia?

Bacterial contamination, lax quality testing and inadequate training of workers were among the issues cited by a team of Food and Drug Administration investigators that wrapped up a two-week inspection of the plant last Friday. (See the FDA report here.)

J&J's McNeil unit, maker and marketer of the products, also failed to investigate 46 complaints from customers about "black or dark specks" in the medicines.

FDA says people shouldn't use the drugs, all liquids, because their quality is uncertain. Even so, FDA Commissioner Margaret Hamburg said in a statement that the "potential for serious health problems is remote."

 

For its part, J&J apologized for the "concern and inconvenience" the recall may have caused and vowed to do a better job. The company has halted production at the factory until the problems identified by the FDA are solved.

Even though the health risks from the recalled product are quite low, Purdue University's Stephen Byrn told USA Today the problems found by FDA undermine confidence in the quality of the medicines made at the plant.

An FDA official in charge of drugmakers' compliance with agency regulations said the agency is considering further action against J&J, depending on the final results of the government's investigation, the Washington Post reported.