BETHESDA, MD 04 February 2009—For the second time in as many weeks, Ethex Corporation announced that the firm is recalling drug products.
The company, a subsidiary of KV Pharmaceutical Company, on Tuesday evening issued two "Urgent Product Recall" notices.
One notice (PDF) details the recall of all strengths of dextroamphetamine, isosorbide mononitrate, morphine sulfate, and propafenone hydrochloride tablets from pharmacies. The company on January 28 had recalled those products from wholesalers but not pharmacies. At the time, the company recalled only hydromorphone hydrochloride and metoprolol succinate tablets from pharmacies.
The other notice (PDF) details the recall of 26 prenatal vitamin and iron supplement products from wholesalers and distributors but not pharmacies.
As with the notices issued last week, Ethex is telling patients who may have any of the products in their possession to continue taking doses in accordance with the instructions on the prescription bottle. Patients who experience any problem possibly related to their use of the Ethex product should contact their health care provider.
The company said it is recalling the products because "they may potentially have been manufactured under conditions that did not fully comply with" current good manufacturing practices.
According to a report the parent company filed with the Securities and Exchange Commission on January 22, FDA started an inspection of the facilities in December 2008 and was not finished. Representatives of FDA`s Office of Criminal Investigations have been participating in the discussions.
Ethex first began recalling products in June 2008 because of the possibility that some of the morphine sulfate tablets were oversize, thus containing more active ingredient than they should.
