The Wall Street Journal just reported that Johnson & Johnsonâ€™s Ethicon unit has issued a recall of 700,000 vials of its <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">Dermabond Wound Product, a liquid wound-sealing product, following reports of discoloration and delayed setting times. The drug maker also recalled a new hernia-treatment productâ€”its Securestrap Hernia Productâ€”over concerns about non-sterile packaging, said a firm spokesman.
Both Defective Medical Device recalls just add to the growing list of recalls and challenges that the drug giant has been facing, most centered around manufacturing issues, in the past two years, pointed out the Journal.
Ethicon notified its customers in a letter dated February 2, stating that it was recalling some of its lots of its Dermabond wound-sealing adhesive following reports it received that some of the units contained discolored product and were taking longer than described to set, said the Journal. Ethicon advised the U.S. Food and Drug Administration (FDA) and noted that it has not, to date, received reports of adverse reactions.
This Defective Medical Device recall involves 31 product lots, including 28 in the U.S., containing 700,000 single-use vials, according to Ethicon spokeswoman Barbara Montresor, wrote the Journal. The firm has in stock, sufficient nonimpacted product, Montresor added, saying that Ethicon is conducting a so-called â€œroot-cause investigation.â€
Ethicon, Inc. is requesting that its customers immediately discontinue use of the Dermabond Adhesive and details how to check the product and identify the recalled products in its letter, which can be accessed at: http://www.ethicon.com/sites/default/files/pdf/DERMABOND%20Voluntary%20Recall%20Notification%20Letter.pdf. The letter also explains how to return the product and notes that credit will only be processed for recalled items and that shipping charges will not be returned if the described shipping label is not used. Ethicon can be reached, toll-free, at 1.866.869.7954.
The Securestrap System Defective Medical Device recall involves a pistol-shaped tool that sends out small, absorbable straps that hold mesh in place in hernia-repair procedures, explained the Journal, which noted that Ethicon began introducing the product late December, but issued a recall when it was found that its sterile packaging barrier might have been compromised, said Montresor. That recall notice was not posted online, said Montresor, because most of the product remained under Ethiconâ€™s control and it was able to identify to which hospitals it had sent the Recalled Product. “We believe we are close to having a correction, a new approach to the packaging for the product,” she said, quoted the Journal.
Earlier this week, we wrote about another Johnson & Johnson recall, that time involving syringes containing an injectable form of the antipsychotic Invega Sustenna because cracks were discovered in some of the products. According to a prior Journal report, this recall was just one in a string of recalls that have cost Johnson & Johnson $900 million in sales over the past year. Other actions include recalls issued by its McNeil Consumer Healthcare division of upwards of 200 million bottlesâ€”including childrenâ€™s formulationsâ€”of Tylenol, Motrin, and other over-the-counter drugs; two ASR hip implants sold by its DePuy Orthopaedics unit; and a recall (an initial action and an expansion) of 100,000 boxes of 1-Day Acuvue TruEye contact lenses.