Find Drug or Device Recall Notices Issued by a Particular Company in the U.S.?

TOPIC: The FDA can request that a manufacturer recall a product and manufacturers usually comply. In some cases, manufacturers recall defective drugs without an FDA request. According to the FDA, recalls fall into three categories:

• Class I: Dangerous or defective drugs that could cause serious health problems or death
• Class II: Drugs that might cause a temporary health problem or pose a remote threat of a serious problem
• Class III: Drugs that are unlikely to cause a health problem, but violate FDA labeling or manufacturing regulations

In many cases, drug recalls are the result of a problem in manufacturing or labeling that affects only a specific "batch" or "lot number" of a drug. In this case, the manufacturer recalls only the drugs that have the defect. Note that the FDA does not have the authority to "order" that a drug be taken off the market. The agency can only order a recall in the case of a threat to human life from infant formula, a medical device or a human-tissue product such as blood. Recall notices as reported in the weekly FDA Enforcement Report are provided in DIOGENES® FDA Regulatory Updates (File 158). DIOGENES contains data on drugs as reported to the FDA by drug manufacturers, individuals, health professionals and medical studies.

In this example you want to find Class III recalls of Medtronic drugs in the years 2004 and 2005.

COMMAND SUMMARY

BEGIN 158
SELECT RECALL? AND CLASS()III
SELECT MEDTRONIC/CO
SELECT S1 AND S2
SELECT S3/2004:2005
Click S4 > Tasks > Picklist
Check records > select format

HOW TO...

1. BEGIN File 158 to search for FDA recall notices. 2. SELECT the type of document you want (e.g., recalls) limited to the class of recall. 3. Limit to the company (/CO) you want to see recalls for, combine sets and limit to current year(s). 4. In the Set Links pane, click S4 > Tasks > Picklist to see the first 10 records in FREE format (titles).
5. Click the check box(es) for the records you want to see in more detail, select the Output/Format and click OUTPUT.
The record shows recall title, date and company affected.

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Stock #: 53332; Last modified: 14 Sep 2011

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