With Johnson & Johnson's consumer healthcare unit partially sidelined by a big recall, you'd think it would be a prime opportunity for Perrigo, which churns out generic versions of many of the recalled meds. Indeed, Mad Money's Jim Cramer touted the company for just that reason: "If Perrigo can scoop up even a large fraction of JNJ's lost sales," Cramer said, "then that would be a big break for this company." But Perrigo is facing manufacturing problems of its own, according to a new warning letter from FDA.
The company recently shipped ibuprofen tablets contaminated with metal shavings, the FDA said in its warning letter, after failing to thoroughly investigate why some tablets came out the wrong size. The company also failed to inspect its packaging equipment between batches. The contaminated tablets have since been pulled from the market, the letter states.
The agency demanded that Perrigo fix its manufacturing problems, or FDA could seize its products, impose an injunction, ban its exports and stop considering its application for new-product approvals.
This isn't the first time Perrigo's manufacturing has run afoul of FDA rules. Four years ago, the company recalled acetaminophen pills that contained pieces of wire as long as 8 millimeters, Bloomberg reports. "Your firm has had an ongoing program since 2005 to address mix-ups," FDA district director Joann M. Givens wrote in the latest warning letter. "However, your firm continues to receive complaints regarding this issue, and despite past assurances that previous enhancements would control the problem, deviations continue."