1. Recalls Neisa M. Alonso Emergency Response Coordinator US FDA / SJN-DO
December 3, 2009

2. What is a Recall?
A "recall" is a firm's removal or correction of a marketed product(s), including its labeling and/or promotional materials, that FDA considers to be in violation of the laws it administers, and against which the agency would initiate legal action (e.g., seizure or the full range of administrative and civil actions available to the agency).

3. Medical device notification or safety alerts are issued by manufacturers, distributors, other responsible parties, or the FDA to inform health professionals or others of risk of substantial harm from a medical device. Medical device notifications are issued at the request of the FDA. Safety alerts are issued voluntarily by the manufacturer.
Other medical device actions include additional options open to manufacturers/distributors. They may take other actions for minor medical device problems or violations that would not necessarily be subject to FDA legal action and do not have the potential to cause serious adverse health consequences. An example of such an action is a device correction notice.

4. When Is a 'Recall' Not a Recall?
MARKET WITHDRAWAL: "Market withdrawal" means a firm's removal or correction of a distributed product which involves a minor violation for which FDA would not initiate legal action, or which involves no violation (e.g., normal stock rotation practices, routine equipment adjustments and repairs, product improvement, etc.) Replacement of device components which fail (wear out) after a reasonable life span will be considered a market withdrawal unless a violation of the FD&C Act has occurred and can be supported (e.g., failure to conduct adequate finished product testing, or sample analysis reveals a defective product.) NOTE: Investigational Product Recovery will normally be considered a market withdrawal unless the product has been sold in domestic commercial distribution or a significant health hazard is involved necessitating classification and publication of the action as a recall.
The removal of products from the market as a result of actual or alleged tampering with individual unit(s), and where there is no evidence of manufacturing or distribution problems, will be considered a market withdrawal.
STOCK RECOVERY: Is another action that may be confused with a recall. A stock recovery is a firm's removal or correction of a product that has not yet been distributed.

5. How do recalls get started?
Recalls may originate in two ways.
1. Firm initiated recalls
- A company discovers on its own that there is a problem with a product and institutes its own corrective recall.
2. FDA initiated recalls
- During an inspection or the results of an FDA sample, FDA will discover a problem and the CSO will inform the company.

6. How do recalls get started?
FDA REQUESTED RECALL: "FDA requested recall" means a recall initiated by a firm in response to a formal request for such action by the Associate Commissioner for Regulatory Affairs, or the appropriate center director when the authority has been delegated.
FDA ORDERED RECALL: "FDA ordered recall" means a recall initiated by a firm in response to an order for such action. Examples would be: device recalls ordered under section 518(e), Infant Formula recalls ordered under section 412(e)(1) of the act, and human tissue for transplantation ordered under the interim regulation [21, CFR Part 1270].
However, if the company does not voluntarily recall the product, then FDA can seek legal action under the FD&C Act.  These include seizure of available product, and/or injunction of the firm, including a court request for recall of the product. Before taking a company to court, FDA usually notifies the responsible person of the violation and provides an opportunity to correct the problem. In most situations, a violation results from a mistake by the company rather than from an intentional disregard for the law.

7. They are FDA guidelines for companies to follow when recalling defective products under the Agency's jurisdiction and are published in Title 21 of the Code of Federal Regulations, Part 7.
These guidelines make clear that FDA expects these firms to take full responsibility for product recalls, including follow-up checks to assure that recalls are successful. Under the guidelines, companies are expected to notify FDA when recalls are started, to make progress reports to FDA on recalls, and to undertake recalls when asked to do so by the Agency.

8. The guidelines also call on manufacturers and distributors to develop contingency plans for product recalls that can be put into effect if, and when needed. FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective.

9. When a company notifies FDA of a recall, the FDA district office releases a "24-Hour Alert to Recall Situation" to appropriate FDA Center. This alert details the product, the company recalling the product, and the reason for the recall.
The FDA will inspect the company and examine reports of illness, injury, or other complaints. These findings, along with product labeling samples, FDA laboratory results, the company’s quality control records, the company’s recall strategy, and often a product sample will be compiled in a Recall Recommendation. This Recommendation is sent to an FDA district recall coordinator.
Generally, FDA accepts reports and other necessary recall information submitted by .  In many cases, this has become routine for some firms and FDA district offices.  However, FDA maintains the prerogative for investigational visits and other in-person communications where the agency considers it appropriate.

10. The Strategy FDA reviews the firm's recall strategy (or, in the rare cases of FDA-requested recalls, drafts the strategy), which includes three things: the depth of recall, the extent of public warnings, and effectiveness check levels. The depth of recall is the distribution chain level at which the recall will be aimed. If a product is not hazardous, a recall aimed only at wholesale purchasers may suffice. For more serious defects, a firm will conduct a recall to the retail level. And if the public health is seriously jeopardized, the recall may be designed to reach the individual consumer, often through a press release. But most defects don't present a grave danger. Most recalls are not publicized beyond their listing in the weekly Enforcement Report published by FDA's press office. The Enforcement Report lists the product being recalled, the degree of hazard (called "classification"), whether the recall was requested by FDA or initiated by the firm, and the specific action taken by the recalling firm.

11. The Health Hazard Evaluation
HEALTH HAZARD EVALUATION: A "health hazard evaluation" is an evaluation by FDA scientists of the threat to health presented by a product, including its labeling and/or promotional materials, that is being recalled or considered for recall. It takes into account, but is not limited to, the following:
1. Deaths, diseases, injuries or other adverse reactions that have already occurred from the use of the product.
2. Existing conditions that could contribute to a clinical situation that could expose humans or animals to a health hazard.
3. Assessment of population who may be at greatest risk (age, physical condition, surgical patients, etc.)
4. Assessment of degree of seriousness of the health hazard to the population at greatest risk (e.g., a product intended for use in emergency room situations.)
5. Assessment of the likelihood of the occurrence of the health hazard.
6. Assessment of immediate or long range consequences of the hazard.
NOTE: See 21 CFR 7.41(a) for a full description of these factors. .

12. This guidelines categorize all recalls into one of three classes according to the level of hazard involved.
• Class I recalls are for dangerous or defective products that predictably could cause serious health problems or death. Examples of products that could fall into this category are a food found to contain botulin toxin, food with undeclared allergens, a label mix-up on a life saving drug, or a defective artificial heart valve.
• Class II recalls are for products that might cause a temporary health problem, or pose only a slight threat of a serious nature. One example is a drug that is under-strength but that is not used to treat life-threatening situations.
• Class III recalls are for products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing regulations. Examples might be a container defect (plastic material delaminating or a lid that does not seal); off-taste, color, or leaks in a bottled drink, and lack of English labeling in a retail food.

13. The company’s recall strategy included in the Recommendation would include: the depth of recall (level of distribution at which the recall will be aimed), the extent of public warnings, and the effectiveness check levels.
Regarding depth of recall, a recall targeting wholesale purchasers may be sufficient if the product is not deemed hazardous. The second tier of recall, for a more serious threat, would involve the retail level. For the most serious cases, the individual consumer will be targeted, often via press releases to the media.
Publicity in the majority of cases is limited to a listing in the FDA’s Enforcement Report. This Report lists the product, class of health hazard, origin of the recall (FDA or company), and action taken by the company.
Effectiveness checks are the responsibility of the recalling company, in which they verify (by personal visit, phone or mail) that every targeted level has been notified. The FDA generally conducts its own Audit Checks, to verify notification and disposal of the product. This occurs only for Class I and Class II recalls.

14. EFFECTIVENESS CHECK LEVEL:
The "Effectiveness Check Level" is an alphabetical term representing the extent to which effectiveness checks will be made within the distribution chain, including consumers or patients where appropriate.
1. Level A--100 percent of the total number of consignees to be contacted (at the specified recall depth).
2. Level B--Some percentage of the total number of consignees to be contacted, which percentage is to be determined on a case-by-case basis, but is greater that 10 percent and less than 100 percent of the total number of consignees to be contacted (at the specified recall depth).
3. Level C--10 percent of the total number of consignees to be contacted (at the specified recall depth).
4. Level D--2 percent of the total number of consignees to be contacted (at the specified recall depth).
5. Level E--No checks.

15. FDA RECALL AUDIT CHECK
The purpose of FDA audit checks is to determine the adequacy of the firm's performance in assuring that all consignees have received notification of the recall and are taking appropriate action. An FDA audit check program should be determined after evaluating the recalling firm's strategy. The audit check levels will either be based upon the effectiveness check levels provided in 21 CFR or on other statistically valid plans. The method for conducting audit checks may be personal visits, telephone calls, or a combination thereof. FDA may be assisted by cooperating federal, state, or local officials in the performance of the audit checks.

16. Recalls Nationwide by Classification 2004-2009

17. Recalls for SJN-DO by Classification 2004-2009

18. Top 10 Recall Reasons for the SJN-DO
OOS
Incomplete Investigations
Undeclared active ingredients
No active ingredients or/and over or under
Empty capsule
Cross Contamination
GMP’s Deviation
Microbiology Contamination
Incorrect Expiration Date
Label Deficiencies

19. The responsibility for an adequate recall belongs to the manufacturer.
The recall is considered complete when, according to the FDA, "all reasonable efforts have been made to remove or correct the product."
The responsibility for an adequate recall belongs to the manufacturer.
The decision and timing of FDA’s recall classification does not change or delay the company’s obligation to take appropriate action.