This Company Repackaged Caraco Digoxin Tablets That Were Recalled March 31, 2009; Why Did They Delay Their Recall Notice?

(Posted by Tom Lamb at DrugInjuryWatch.com)

On May 11, 2009 AS Medication Solutions, LLC — which is a drug repackage company –announced that it has recalled all tablets of Caraco digoxin tablets because those pills may differ in size and therefore could have more or less of the active ingredient, digoxin.

If this sounds vaguely familiar, it should.  On March 31, 2009 Caraco Pharmaceutical Laboratories issued a recall notice for all of its digoxin tablets due to pill-size problems.

Why did it take AS Medical Solutions until mid-May to issue its recall notice for the Caraco digoxin tablets that it simply repackaged and distributed when Caraco recalled its digoxin pills at the end of March 2009?

From the company's May 11 press release, "AS Medications Solution LLC. Announces a Nationwide Recall of All Lots of Digoxin Tablets 0.25mg Due to Size Variability":

Digoxin is a drug product used to treat heart failure and abnormal heart rhythms. It has a narrow therapeutic index and the existence of higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and slow heart rate. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of heart failure and abnormal heart rhythms.. Consequently, as a precautionary measure, A S Medication Solutions, LLC is recalling these tablets to the consumer level to minimize any potential risk to patients.

Consumers with the products with the following NDC codes that are within expiration should return these products to the place of purchase.

Product Identification

Caraco Digoxin
A-S Medication Solutions, Digoxin 0.25 mg is a scored round biconvex white tablet imprinted with “441”

NDC Numbers:
Digoxin Tablets, USP, 0.25 mg
54569-5758-0 (30-count)

As seen above, the company's press release suggests that patients who have any remaining A-S Medication Solutions digoxin 0.25 mg tablets should return those pills to the pharmacy where they were purchased.

If, however, a patient suffered from digitalis toxicity, low blood pressure, cardiac instability, or bradycardia (slow heart rate) while using A-S Medication Solutions digoxin pills, I urge you not to return those pills because they may be important evidence in any possible personal injury or wrongful death case.

In closing, I will ask once again:  What took this drug repackaging company so long to issue its digoxin recall knowing that the A-S Medication Solutions digoxin 0.25 mg tablets it was distributing were the Caraco digoxin pills that had been recalled at the end of March 2009?