“American consumers are entitled to have safe and effective drugs,” said Hanaway.

The seizure followed an inspection of several of the company’s plants where FDA investigators found that the company was not complying with an FDA enforcement notice as well as manufacturing unapproved new drugs such as products for cough, cold, topical wound healing, skin bleaching, and gastrointestinal conditions, as well as narcotic drug products.

“The FDA is committed to taking enforcement action against firms that circumvent the drug approval process,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research (CDER). “Consumers need to be confident that the drugs and medical products they use are safe and effective, and the FDA will take the necessary measures to ensure safety and effectiveness throughout the lifecycle of the product, including keeping the product from reaching the marketplace.”

In a routine inspection of KV Pharmaceutical’s facilities in early 2008, the FDA found the company was violating its May 29, 2007, notice (72 FR 29517) requiring companies to stop manufacturing all timed-release drug products containing guaifenesin, including combination drug products in which guaifenesin is in immediate release form, but another ingredient in the combination drug product is in timed-release form, because they are unapproved new drugs. FDA took the action as part of its effort to ensure that all drugs marketed in the United States have the required FDA approval and that they are safe, effective, of good quality, and are appropriately labeled. For products in timed-release form, FDA approval is also necessary to make sure that the product releases its active ingredients at the correct rate. Improperly manufactured timed-release products may release the active ingredients too quickly, too slowly, or not at all, making the product unsafe or ineffective.

The FDA required companies to stop manufacturing the affected products before August 27, 2007, and to stop shipping the products before November 26, 2007. KV Pharmaceutical continued to manufacture and ship these unapproved new drugs after the cessation dates.

The inspection also exposed the company’s manufacturing and distribution of other unapproved drug products. Today’s action addresses numerous unapproved drug products manufactured and distributed by the company.

The following drug products were seized and will be destroyed:

• PhenaVent Capsules
• PhenaVent LA Capsules
• PhenaVent PED Capsules
• Ethezyme Papain-Urea Ointment
• Ethezyme 650 Papain-Urea Ointment
• Ethezyme 830 Papain-Urea Ointment
• Hista-Vent DA Tablets
• Meperidine/Promethazine Capsules
• Pseudovent Capsules
• Pseudovent 400 Capsules
• Pseudovent PED Capsules
• Tri-Vent DM Syrup
• Tri-Vent DPC Syrup
• Hydro-Tussin DM Liquid
• Hydro-Tussin CBX Syrup
• Hydro-Tussin DHC Syrup
• Hydro- Tussin EXP Syrup
• Hydro-Tussin HD Syrup
• Hyoscyamine Sulfate Sublingual Tablets
• Hydroquinone 4% Cream
• Hydroquinone 4% Cream with Sunscreen
• Bromfenex Extended Release Capsules
• Bromfenex PD Extended Release Capsules

The seized drugs had been held under embargo by the state of Missouri. Since the time of the embargo, KV Pharmaceutical has been cooperating with FDA officials.

“The FDA will take action against companies that continue to manufacture or market an unapproved product after the marketing or distribution cessation date,” said Deborah M. Autor, director of the FDA’s Office of Compliance within CDER. “When a company does not heed a cessation date relating to a specific product, the FDA will take enforcement action relating to the company’s other unapproved drugs.”

In June 2006, the FDA issued a guidance document titled, “Marketed Unapproved Drugs—Compliance Policy Guide (CPG).” This CPG makes clear that companies may not market drugs that require approval without first establishing, through applications for approval, that the products are safe and effective.

The FDA encourages consumers who may have these products to contact their health care professional about FDA-approved treatments and discard these products.

Source: FDA

Recall Insider

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