Who is responsible for drug recalls

The FDA maintains a list of drug and medical device recalls on its website www. For the most part, this list includes Class I safety recalls. Media coverage. Often, if a drug recall affects many people, or the recalled drug causes severe injury or death, the media will report on the recall. The FDA encourages consumers and healthcare professionals to report problems they suspect are caused by drugs, vaccines, or medical devices, including:. Department of Health and Human Services' website at www.

If you have been harmed by use of a pharmaceutical or over-the-counter drug, you may be able to bring a product liability claim against the drug manufacturer. The information provided on this site is not legal advice, does not constitute a lawyer referral service, and no attorney-client or confidential relationship is or will be formed by use of the site.

The attorney listings on this site are paid attorney advertising. In some states, the information on this website may be considered a lawyer referral service. Please reference the Terms of Use and the Supplemental Terms for specific information related to your state. Grow Your Legal Practice. Meet the Editors. FDA Drug Recalls. When the FDA or a pharmaceutical company removes a drug from the market, what does it mean?

Recent examples of drug recalls include: McNeil Consumer Healthcare's April recall of certain batches of over-the-counter children's drugs, including liquid Tylenol, Motrin, and Zyrtec because of possible contaminants. The recall of Baxter Healthcare's anticoagulant drug, heparin, because the FDA found contaminants in the drug that caused severe injury and death in some people. For more on the heparin recall, see Nolo's article Heparin Recall and Litigation. Crestor and other cholesterol drugs Read on to learn how the FDA approves and monitors drugs, when and how recalls occur, and how to notify the FDA if you suspect a serious problem with a drug.

When Are Drugs Recalled? This could be because of any of the following: The drug causes dangerous side effects. The FDA has discovered a safer alternative to the drug.

December 8, Center for Devices and Radiological Health. Recalls, corrections and removals devices. Updated July 9, FDA product recalls.

Updated September 10, American Pharmacists Association. Drug recalls put spotlight on drug supply chains. November 21, Smith M. November 19, Accessed March 30, Lupkin S, DeMarco H. When medicine makes patients sicker. Kaiser Health News. January 4, Higgins C. Drug recalls are more widespread than previously thought. Pharmacy Today. February 19, A recall is a voluntary action taken by a company to remove a defective drug product from the market.

Public notification is generally issued when a product that has been widely distributed or poses a serious health hazard is recalled.

However, if a company does not issue public notification of a recall, FDA may do so if the agency determines it is necessary to protect patients. Stock recovery means the correction or removal of a device that has not been marketed or that has not left the direct control of the manufacturer, i. A recall is an alternative to an FDA-initiated court action for removing or correcting violative products that have been distributed.

Recall may be undertaken voluntarily and at any time by manufacturers and distributors, or at the request of the FDA. A request by the FDA that a firm recall a product is reserved for urgent situations and is directed to the firm that has primary responsibility for the manufacture and marketing of the product that is to be recalled. Recall does not include market withdrawal or a stock recovery.

A market withdrawal is a firm's removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the FDA or which involves no violation, e. Almost all recalls are conducted on a voluntary basis by the manufacturer.

Please note an electronic product that emits radiation and is subject to 21 CFR and is not subject to the requirements under 21 CFR 7. An evaluation of the health hazard presented by a product being recalled or considered for recall is conducted by FDA and takes into account, but need not be limited to, the following factors:. On the basis of this determination, the FDA will assign the recall a classification, i. The recalling firm should develop a recall strategy that takes into account the following factors as they apply to the individual circumstances of the particular recall:.

The FDA will review the adequacy of a proposed recall strategy and recommend changes as appropriate. A recalling firm should conduct the recall in accordance with an approved recall strategy but need not delay initiation of a recall pending review of its recall strategy.

A firm may choose to remove or correct a distributed product for any reason and under any circumstance. If a firm does this because it believes its product is violative, it is required to immediately notify the FDA. Such removal or correction will be considered a recall only if the FDA determines the product is violative. In such cases, the FDA will ask the firm to provide this information:.

The FDA will review the information submitted, advise the firm of the assigned recall classification, recommend any appropriate changes in the firm's strategy for the recall, and advise the firm that its recall will be placed in the weekly FDA Enforcement Report. Pending this review, the firm need not delay initiation of its product removal or correction.

A firm may decide to recall a product when informed by the FDA that the agency has determined that the product in question violates the law, but the agency has not specifically requested a recall. A firm that initiates a removal or correction of its product which the firm believes is a market withdrawal should consult with its DRC if the reason for the removal or correction is not obvious or clearly understood but where it is apparent, e. In such cases, the FDA will assist the firm in determining the exact nature of the problem.

A recalling firm is responsible for promptly notifying each of its affected direct accounts about the recall. The format, content, and extent of a recall communication should be commensurate with the hazard of the product being recalled and the strategy developed for that recall.

In general terms, the purpose of a recall communication is to convey:. A recall communication can be accomplished by telegrams, mailgrams, or first class letters conspicuously marked, preferably in bold red type, on the letter and the envelope: "medical device recall [or correction]".

The recall communication should not contain irrelevant qualifications, promotional materials, or any other statement that may detract from the message. Where necessary, follow-up communications should be sent to those who fail to respond to the initial recall communication.

A recalling firm is encouraged to discuss the recall letter with its DRC prior to issuing the notification. Consignees that receive a recall communication should immediately carry out the instructions set forth by the recalling firm and, where necessary, extend the recall to its consignees in accordance with the instructions described above. The recalling firm is requested to submit periodic recall status reports to the its DRC so that the agency may assess the progress of the recall.

The frequency of such reports will be determined by the relative urgency of the recall and will be specified by the FDA in each recall case; generally the reporting interval will be between 2 and 4 weeks. Unless otherwise specified or inappropriate in a given recall case, the recall status report should contain the following information:.

A recall will be terminated when FDA determines that all reasonable efforts have been made to remove or correct the product in accordance with the recall strategy, and when it is reasonable to assume that the product subject to the recall has been removed and proper disposition or correction has been made commensurate with the degree of hazard of the recalled product.

Written notification that a recall is terminated will be issued by its DRC to the recalling firm. A recalling firm may request termination of its recall by submitting a written request to its DRC stating that the recall is effective in accordance with the criteria set forth, and by accompanying the request with the most current recall status report and a description of the disposition of the recalled product.

FDA publishes a weekly FDA Enforcement Report that contains all enforcement actions including recalls, field corrections, seizures, and injunctions. A recall can be disruptive of a firm's operation and business, but there are several steps a firm can take in advance to minimize this disruptive effect. Notwithstanding similar requirements under the Quality System regulation 21 CFR , the firm should take into consideration:.