Pharmaceutical Manufacturers Expand Massive Drug Recall

KV Pharmaceutical Co. and its subsidiaries have expanded a recall initiated late last year to include a total of more than 90 drug products. The products were recalled for failing to comply with current Good Manufacturing Practice regulations established by the FDA.

KV subsidiary Ethex Corp. said in a Jan. 28 news release that patients who have these medications "should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medication may place patients at risk."

Furthermore, the company said that patients should contact their physicians "if they have experienced any problems that may be related to taking or using these products or to obtain replacement medications or prescriptions."

Ethex recalled 5-mg tablets of dextroamphetamine sulfate in October 2008 because of the possible presence of oversized tablets. The company said in a news release at the time that the oversized tablets may contain twice the labeled amount of the active ingredient.

In December, the company recalled 2-mg tablets of hydromorphone hydrochloride because of the possible presence of oversized tablets.

KV Pharmaceutical said at that time it would voluntarily suspend shipments of all FDA-approved drug products in tablet form as a precautionary measure. The company also said that it planned to "expeditiously address manufacturing issues."

On Jan. 26, KV announced that it had voluntarily suspended the manufacturing and shipping of all of its products, with the exception of some products that it distributes but does not manufacture. KV said it is cooperating with an FDA inspection of the company’s operations and inventory.

Ethex had recalled more than 60 products at the wholesale level and seven at the retail level in late January, but the company added to its list of products recalled at the retail level in early February.

On Feb. 3, Ethex recalled more than 20 versions of the company's prescription prenatal vitamins, as well as four prescription iron supplement products. KV subsidiary Ther-Rx-Corp., also recalled its prescription prenatal vitamins and prescription iron supplements.

In addition to the recalls, KV acknowledged in its Jan. 26 news release that it is facing a "series of putative class action shareholder lawsuits alleging violations of the federal securities laws by the company," as well as an informal inquiry by the U.S. Securities and Exchange Commission.