Korea Suspends J&J Subsidiary Production Of 4 OTCs

The Ministry of Food and Drug Safety orders a halt to manufacturing of five products after an investigation of GMP deviations at J&J’s Korean unit. Production of each of the products will be halted between one and five months.

South Korea’s Ministry of Food and Drug Safety suspended production of four OTC products, including a Children’s Tylenol product, and one Rx drug made at Johnson & Johnson’s Janssen Korea facility due to good manufacturing practices deviations.

MFDS in April ordered Janssen Korea’s Hwasung factory, outside of Seoul, to undergo a two-week inspection to determine whether GMP regulations were violated. The probe was ordered after Janssen Korea delayed reporting problems that led to a recall of its Children's Tylenol liquid (acetaminophen) for excessive amounts of acetaminophen, which could cause liver damage if taken in excess (Also see "In Brief" - Pink Sheet, 13 May, 2013.).

Janssen Korea delayed suspending sales of Children’s Dye-Free Tylenol liquid even after safety issues were known, MFDS said May 16. Production of the pediatric product will be stopped for five months.

“After the overall probes into the manufacturing and quality control of all products produced in Janssen Korea’s Hwasung plant, we found violations of five products and have decided to take administrative measures of production suspension from one month to five months,” said the agency, recently renamed from the Korea Food & Drug Administration.

“Janssen Korea bought new equipment in 2011; we know some medicines since then have been filled by hand in the late-stage [manufacturing] process,” an MFDS official said, noting she did not know if the new equipment was malfunctioning.

Production of dandruff shampoo Nizoral (ketoconazole) will be suspended for four months because it also was filled by hand, according to the agency.

In addition, production of proton pump inhibitor Pariet (rabeprazole), pain reliever Ultracet (acetaminophen/tramadol) and Rx attention deficit-hyperactivity disorder drug Concerta (18 mg methylphenidate) will be suspended for one month because Janssen did not conduct proper process-validation procedures after facility changes were introduced in the plant, which manufacturers 42 products in total, MFDS said.

Restore Trust And Confidence

Noting that Children’s Dye-Free Tylenol liquid – Cherry Flavor, in 100- and 500-mL sizes – was the only Janssen product subject to a recall in Korea, the company said it would move to restore trust and public confidence in its products.

“All other products subject to a production suspension are currently available and remain safe for use,” Janssen Korea said in a press statement. The firm “recognizes the significance of findings released today by the Ministry of Food and Drug Safety and the proposal to temporarily suspend production of five products.”

A global team of experts has been sent to Korea to assess the situation, Janssen Korea said. Officials declined to comment further.

The incident is the latest in a series of manufacturing issues for J&J’s consumer health business. In the U.S. the firm’s McNeil Consumer Healthcare subsidiary is operating under a consent decree with FDA that has kept top products off the market as the business works through a manufacturing remediation and product restoration plan ( (Also see "McNeil Remediation Stretches Out, Dragging On J&J Consumer Sales" - Pink Sheet, 23 Apr, 2012.)).

[Editor’s note: This story was contributed by PharmAsia News, which provides daily coverage of the Asia biopharmaceutical industry and regulatory policies. To sign up for a free trial, call 1-800-322-2181 or click here – no credit card needed.]