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 2005 and 2006.

*Covers 1976-2011.

COMMAND SUMMARY

BEGIN 158
SELECT RECALL? AND CLASS()III
SELECT MEDTRONIC/CO
SELECT S1 AND S2
SELECT S3/2005:2006
TYPE S4/6/1-5
TYPE S4/9/1

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).	?b 158 File 158:DIOGENES(R) 1976-2006/Jun W4        (c) 2006 DIOGENES         Set  Items  Description       ---  -----  ----------- ?SELECT RECALL? AND CLASS()III            44725  RECALL?          1398035  CLASS            20028  III             9151  CLASS(W)III       S1    8867  RECALL? AND CLASS()III ?SELECT MEDTRONIC/CO       S2   76203  MEDTRONIC/CO ?S S1 AND S2             8867  S1            76203  S2       S3      43  S1 AND S2 ?S S3/2005:2006               43  S3             1523  PY=2005 : PY=2006       S4       6  S3/2005:2006
4. TYPE all records to see any Class III recalls Medtronic is involved in.	?T S4/6/ALL     4/6/1   02532872   DIOGENES RECORD NUMBER: E0149733  Medtronic Paceart   CLASS    III  RECALL 02/??/06:  Software.   WORD COUNT:            204     4/6/2   02532871   DIOGENES RECORD NUMBER: E0149732  Medtronic Puerto Rico   CLASS    III  RECALL 03/??/06:  Neurostimulator.   WORD COUNT:            190     4/6/3   02532668   DIOGENES RECORD NUMBER: E0149393  Medtronic Navigation   CLASS    III  RECALL 02/01/06:  Knee Kit.   WORD COUNT:             78     4/6/4   02532077   DIOGENES RECORD NUMBER: E0148770   Medtronic  Sofamor  Danek Instrument Manufacturing CLASS   III   RECALL 12/01/05:  Screw Driver.     WORD COUNT:             59     4/6/5   02531973   DIOGENES RECORD NUMBER: E0148498  Medtronic MiniMed CLASS   III   RECALL 04/27/05: Instructional Booklet.     WORD COUNT:            123     4/6/6   02530508   DIOGENES RECORD NUMBER: E0146547  Medtronic Neurosurgery   CLASS    III  RECALL 02/28/05:  Medical Scopes.   WORD COUNT:             74
5. TYPE any complete records you want to view in more detail using Format 9. The record shows recall title, date and company affected.	?t s4/9/5   4/9/5   DIALOG(R)File 158:DIOGENES(R) (c) 2006 DIOGENES. All rts. reserv.   02531973   DIOGENES RECORD NUMBER: E0148498  Medtronic MiniMed CLASS   III   RECALL 04/27/05: Instructional Booklet.     BRAND  NAME: "Fine Tuning Your Pump" booklt provided with model MMT-515 &   MMT-715 insulin infusion pumps.   DRUG NAME: Instructional booklet.   COMPANY NAME:  Medtronic   MiniMed, Northridge, CA.   SOURCE: FDA ENFORCEMENT REPORT 11/23/2005.   PUBLICATION DATE: April 27, 2005 (  20050427)   )   RECORD TYPE: Fulltext   WORD COUNT:            123  (Short)   DOCUMENT TYPE:   DEVICE  (DEV)   LANGUAGE: English   PRODUCT   "Fine  Tuning  Your Pump" booklet provided with Model MMT-515 and MMT-715 Insulin Infusion Pumps,  Recall   # Z-0162-06   CODE All models shipped between October 1, 2004 and April 5, 2005.   RECALLING   FIRM/MANUFACTURER   Medtronic  MiniMed,  Northridge,  CA,  by  letter on April 27, 2005. Firm initiated  recall is ongoing.   REASON   The text description of how to perform insulin sensitivity testing and associated  worksheet included in the booklet that is shipped with the Paradigm  515 and Paradigm 715 insulin pumps contained a basic flaw in that the  blood  glucose  after  the correction should be compared to the target glucose  and  it  says  compare to the beginning blood glucose in the procedure.   VOLUME OF PRODUCT IN COMMERCE Approximately 14,560   DISTRIBUTION Nationwide, Bahamas, Bermuda, Canada, Mexico, and PR

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Stock #: 54332; Last modified: 2 Nov 2012

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