20.Sep.2009 at 20 | DavidV
Care-Tech® Laboratories, Inc. Suspends Manufacturing and Distribution of OTC Drug Products
ST. LOUIS, MO, September 14, 2009/ – - Care-Tech® Laboratories, Inc. announces that it has suspended manufacturing and distribution of its drug products to address concerns raised by the U.S. Food and Drug Administration (FDA). Specifically, the FDA has informed Care-Tech® that it believes the company’s over-the-counter (OTC) drug products have not been manufactured, processed, packed, and held consistent with current good manufacturing practice for drugs, which makes them presumptively adulterated under the law, even where, as here, no finished product has been found to be defective. FDA also has informed Care-Tech® that it believes these products do not conform to an OTC drug monograph, and so are considered unapproved drugs. Accordingly, Care-Tech® has agreed to suspend manufacturing and distribution of our drug products until we have fully resolved these concerns. Care-Tech® has already taken significant steps to address the issues FDA has brought to our attention, and we are working closely with agency officials to ensure any remaining issues are resolved as expeditiously as possible.
Neither FDA nor Care-Tech® is aware of any reports of injury or illness related to the use of these products, and FDA has not requested that previously distributed product be recalled. “The company is committed to ensuring that each of its products reflects the highest standards of safety and purity,” says John C. Brereton, President. “For over 100 years, patient safety has been Care-Tech® Laboratories’ first and foremost commitment. And I can assure you, it remains so today.”
The company intends to update its customers as further information becomes available.
