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FDA Mandated Recalls FDA and deal specifically with Class I recalls that can have a
Under very limited circumstances, federal statute authorizes catastrophic effect on those who take/use the product. Based
the FDA to order a mandatory recall of a product.10 Subjects on the gravity of the situation, the FDA will issue a public
of mandatory recalls can include: devices, biological products, warning. The FDA mandatory recalls are narrowly restricted
human tissue intended for transplantation, infant formula, by the statute and the FDA will only authorize a manufacturer
tobacco products, and food.11 The FDA also has discretion to recall if it fits within the parameters of the statute.
order a mandatory recall if it finds that a human cell, tissue,
or cellular or tissue-based product, is a source of dangerous in- To read more about FDA recalls, please visit the
fection to humans, or does not adequately protect against the FDA’s Regulatory Process Manual found online.
transmission of communicable disease.12
1 http://www.fda.gov/Safety/Recalls/ucm165546.htm
Each FDA mandated recall follows specific timelines and pro- 2 http://www.fda.gov/downloads/ICECI/ComplianceManuals/
cedures depending on the circumstances.13 For example, each RegulatoryProceduresManual/UCM074312.pdf; http://www.fda.gov/
recall is initiated with a written order that states the violation, MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/
the product, lot and serial numbers to be recalled, and the RecallsCorrectionsAndRemovals/.
timeline for the recall. Each recall is unique and requires its 3 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
own strategy developed by the Center Recall Unit (CRU).14 The PostmarketRequirements/RecallsCorrectionsAndRemovals/#3
CRU will consider how far the recall should extend, whether the 4 http://www.fda.gov/downloads/ICECI/ComplianceManuals/Regulatory
public needs to be warned and if so, in what geographical area, ProceduresManual/UCM074312.pdf
and the appropriate assessment level for recall effectiveness.15 5 http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2014/08/
who-can-recall-what-fdas-mandatory-recall-authority-is-a-us-district-
The Recall Differences court-could-not.html
The major difference between voluntary, requested, and man- 6 Id.; 7 Id.; 8 Id.; 9 Id.; 10 Id.; 11 Id.
datory recalls is who initiates the process. With voluntary re- 12 http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2014/08/
calls, the manufacturer of the product initiates the recall and who-can-recall-what-fdas-mandatory-recall-authority-is-a-us-district-
it is the manufacturer’s responsibility to contact the direct ac- court-could-not.html
counts about the recall. Requested recalls are initiated by the 13 Id.; 14 Id.; 15 Id.

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ADYNOVATE is a registered trademark of Baxalta Incorporated, a wholly owned, indirect subsidiary of Shire plc.
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Summer 2017 | Dateline Federation 11