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Actavis Reopens Plant Closed After Digitek, Other Drug Recalls

Apr 20, 2009 | Parker Waichman LLP Actavis Totowa has received approval from the Food & Drug Administration (FDA) to reintroduce Oxycodone tablets made at its Little Falls, NJ facility.  The Little Falls plant was one of three closed last year following recalls of oversized Digitek (Digoxin) tablets and other defective generic drugs.

Actavis agreed to temporarily close its Little Falls manufacturing facility, as well as another in Riverview and a packaging plant in Taft as part of a Consent Decree it reached with federal regulators.  Last April, Actavis recalled Digitek tablets, some of which were made in Little Falls.  Actavis said at the time that some Digitek tablets might have been oversized, and could expose patients to a dangerously high level of the drug’s active ingredient.  The FDA deemed the Digitek recall a Class I recall, meaning that the defective Digitek tablets could cause serious health problems or death. A double-strength Digitek tablet poses a serious risk of digitalis toxicity in those patients suffering from renal failure.

Finally in August, Actavis issued another recall of all generic drugs made at the Little Falls facility.  That recall was prompted by an inspection at the facility which revealed that operations did not meet the FDA’s standards for good manufacturing practices.

A report issued in December by the Center for Public Integrity found that the number of fatalities associated with Digitek spiked around the time of the recall.  According to the report, there were 667 deaths reported to the FDA Adverse Events Reporting System that involved Digitek between April 1 and June 30.  The group also found that  FDA had received just one reported death attributed to Digitek in the previous three-month reporting period. The Center says the FDA has confirmed the findings of its analysis.

After the August recall, Actavis finally closed the New Jersey plants to institute “remediation” efforts.  But the company sought to reopen the facilities, prompting the Justice Department to file a lawsuit in November to force their closure. Under the Consent Decree reached the following month, Actavis  agreed to not distribute any products from the closed facilities until it has certified completion of certain enumerated requirements that demonstrate compliance with FDA’s current good manufacturing practice and has passed follow-up FDA inspections of the facilities.  The Consent Decree settled issues identified by the Justice Department lawsuit.

According to an Actavis press release issued late Friday, the FDA completed its inspection of Little Falls and approved the release of the first two products as outlined in the Decree: Oxycodone 15 mg and 30 mg tablets. Subsequent inspections, also as outlined in the Decree, will follow, the release said.

"Through an extensive process, Actavis re-qualified all equipment and utilities for production and packaging - and we re-qualified and revalidated all methods used to release products from our Totowa facilities," Nasrat Hakim, Vice President of Quality Compliance and Technical Services for Actavis Inc. said in the company's statement. "This is a very positive step and took incredible team work. The next step in the process will involve additional interaction with the FDA so that we can continue to introduce products as outlined in the Consent Decree."

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