In some cases, a drug product must be recalled due to a problem occurring in the manufacture or distribution of the product that may present a significant risk to your health and cause substantial injury. According to a report in 2005 by the Federal Drug Administration, the most common reasons for drug recalls include
- Microbial contamination of non-sterile products
- Lack of efficacy
- Impurities/degradation products
- Lack of assurance of sterility
- Lack of product stability
- Labeling: Label error on declared strength
- Misbranded: Promotional literature with unapproved therapeutic claims
- Labeling: Correctly labeled product in incorrect carton or package
Manufacturers or distributors usually implement voluntary recalls in order to carry out their responsibilities to protect the public health when they need to remove a marketed drug product that presents a risk of injury to consumers or to correct a defective drug product. A voluntary recall of a drug product is more efficient and effective in assuring timely consumer protection than an FDA-initiated court action or seizure of the product.
Gelch & Associates, P.A. represent persons injured by drugs in the marketplace. For more information call us at 866-780-HURT (4878).