Following Digitek recall, Actavis issues recall for 65 other drugs made at same plant
On Monday, Actavis Totowa, LLC, the maker of Digitek, recalled over 65 different generic drugs made at their New Jersey manufacturing plant. Following an FDA inspection earlier this year, a number of violations of good manufacturing practices were identified. In April 2008, Actavis issued a Digitek recall for all lots of their generic digoxin which were made at the same plant, after they discovered that tablets had been commercially sold which were twice as thick as they were supposed to be.
>>PRIOR POST (5/4/2008): Digitek Recall Due to Risk of Digoxin Overdose
Actavis Totowa, LLC, is a generic drug maker who produces a variety of different medications at the plant in Little Falls, New Jersey. An FDA inspection uncovered a number of violations of the proper standards for manufacturing drugs and poor quality controls, leading the company to ask pharmacies and hospitals to return all medications they produced.
>FDA LINK: Complete List of Medications Impact by Actavis Recall
In April 2008, Digitek tablets produced at this same New Jersey plant were recalled after it was discovered that some tablets were twice the width and twice as strong as they were supposed to be. The FDA issued a Class I Digitek Recall because use of the defective digoxin tablets could cause serious and potentially fatal digoxin overdose.
The Digitek lawyers at Saiontz & Kirk have been investigating potential lawsuits for users of the heart medication since the recall was announced. Hundreds of users have reported severe illnesses after taking the defectively manufacturered tablets, including vomiting, diarrhea, nausea, dizziness, low blood pressure, heart instability, vision changes and breathing problems.
Since the Digitek recall, Actavis has provided very little information about the extent of the manufacturing problems which led to the defective tablets. Many have expressed concerns about the safety of other products made at the same plant, since quality checks at the plant allowed the obviously defective Digitek pills to be sold throughout the United States.
It is unclear why the recall of other drugs made at the plant was not issued earlier. In fact, evidence of manufacturing problems at this New Jersey plant were present well before the Digitek recall was issued in April. The FDA has sent prior warning letters to Actavis Totowa LLC in February 2007 and August 2006 about poor manufacturing practices at the plant.
>>PRIOR POST (5/21/2008): Manufacturing Problems at Digitek Plant
Previous FDA inspections identified various violations of good manufacturing processes, including inadequate cleaning processes between the manufacture of different drugs and one machine which was strapped with duct tape to prevent powder from escaping. In May 2006, a batch of hydrochloprothiazide tablets made at the Little Falls, New Jersey plant cleared Actavis’ quality control checks even though they did not meet the appropriate specifications for hardness.
Oddly, Actavis has only issued this latest recall for medications that are still at the retail level, at hospitals and pharmacies. Consumers who have received any of the recalled generic drugs have been advised by Actavis that they should not stop taking their medication, as suddenly stopping could have adverse health effects. Information posted on their website indicates that “if patients are concerned and wish to consider switching medicines, they should first consult with their health care providers or pharmacists.”
ACTAVIS RECALL LAWSUIT
The Digitek recall lawyers at Saiontz & Kirk are monitoring the facts surrounding this latest recall from Actavis Totowa. It is unclear what, if any, specific health risks could be associated with the prescription drugs manufactured at this plant. If you, a friend or family member have suffered adverse reactions or side effects to any of the recalled generic drugs made at the New Jersey plant, request a free consultation and claim evaluation.
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