Oversized Generic Tablet Recall

 

Ethex, a manufacturer of generic medications, has voluntarily recalled multiple medication lots for five different drugs, due to the possible presence of oversized tablets. The recalled tablets include 150 mg, 225 mg, and 300 mg Propafenone HCl Tablets; 30 mg and 60 mg Isosorbide Mononitrate Extended Release Tablets; 15 mg Morphine Sulfate Extended Release Tablets; 15 mg and 30 mg Morphine Sulfate Immediate Release Tablets; and 10 mg Dextroamphetamine Sulfate Tablets. Oversized tablets may contain up to twice the labeled amount of active ingredients and pose significant safety risks. The same manufacturer recently recalled several lots of oversized 5 mg Dextroamphetamine Sulfate tablets.

Patients may be unaware that these drugs were dispensed to them. Often, patients refer to their medications by the original brand name, even if their prescription was filled with a generic substitution. While only generics from a single manufacturer were recalled, patients should check their medications and consult with the pharmacy where they obtained them to see if they are impacted by the recall.

Propafenone HCl is a generic for the antiarrhythmic drug Rythmol. Adverse events seen with excessive dosing of propafenone include arrhythmias and hypotension. Recalled lot numbers of 150 mg tablets are: 73761, 78184, 79373, 81240, 81241, 81242, 83470, 84357, 90525, and 90526. These lots have expiration dates ranging from 3/2009 to 3/2011. 225 mg lots recalled include: 71720, 74831, 76014-15, 81243-45, 89731, 90527-29, and 90657. These lots have expiration dates ranging from 3/2009 to 2/2011. 300 mg lots recalled include: 72834, 76016-18, 81246, 89092, 89732, 90530, 90532, and 91641-42. Expiration dates for these lots range from 6/2009 to 3/2011.

Isosorbide mononitrate is a generic for the anti-anginal drugs Ismo, Imdur, and Monoket. Adverse events seen with excessive dosing of isosorbide mononitrate include fainting and hypotension. The 30 mg tablet recalled lot numbers are: 62355, 66423, and 68102. These tablets have expiration dates ranging from 11/2008 to 8/2009. The recalled 60 mg Isosorbide Mononitrate Extended Release Tablets are from lot numbers: 63466, 66034, 67351, and 67354. These tablets have expiration dates ranging from 12/2008 to 11/2009.

Morphine sulfate is an opioid pain reliever. Adverse events seen with excessive dosing include respiratory depression and hypotension. The 15 mg extended release tablet may be dispensed as a generic for MS Contin. Recalled lot numbers for the 15 mg extended release tablets are: 81175, 82514-16, 89660, 89664, 89667, 90249-51, and 91687. These tablets have expiration dates ranging from 12/2008 to 2/2010. Because there is no brand name drug for immediate release morphine sulfate, patients would not identify it under any other name. The 15 mg immediate release tablets recalled are from lots 77852-54, 81746, 82519-20, 84113, and 90276-78 and have expiration dates ranging from 9/2009 to 1/2011. The 30 mg immediate release tablets recalled are from lots 75093, 77855-57, 82297, 82521-22, 87239, 88925, and 90288-98 and have expiration dates ranging from 8/2009 to 3/2011.

Dextroamphetamine Sulfate is approved for the treatment of narcolepsy, attention deficit disorder, and attention deficit hyperactivity disorder. It is only available as a generic. Adverse events associated with excessive dosing of Dextroamphetamine Sulfate include tremors, decreased appetite, headache, insomnia, dizziness, blurred vision, stomach upset, and dry mouth. Other, more serious adverse events include tachycardia, hypertension, psychotic episodes, a new onset or worsening of tics and dyskinesias. The recalled 10 mg tablets came from lot numbers 73934, 75892, 77945, 81137, 86320 and have expiration dates ranging from 6/2009 to 5/2011.

Excessive dosing of either morphine sulfate or Dextroamphetamine sulfate may also result in physical impairment and altered coordination when operating machinery or driving, posing both individual and public safety risks.

It is prudent to encourage all patients and caregivers to check their medications. Consumers and their caregivers should not use any tablets that appear to be oversized. They should speak with their pharmacist and prescribing health care provider for further instructions. Patients experiencing any adverse reactions associated with abnormally sized tablets should contact the FDA’s