Page 9 - HFA Dateline 2019-2020 Special Issue

in the FDA Weekly Enforcement Report. Nearly all recalls System. The RES is a database used by the FDA to submit,
implemented in the U.S. are begun on a voluntary basis by update, classify and terminate recalls.
the manufacturer.
FDA Mandated Recalls
If a manufacturer has voluntarily initiated a recall, it is
the manufacturer’s responsibility to promptly notify each The FDA’s authority to issue a mandatory recall is
of its direct accounts. If the recall extends beyond direct very limited. Subjects of mandatory recalls can include
accounts, then the direct accounts should be instructed by devices, biological products, human tissue intended for
the recalling manufacturer to contact sub-accounts that transplantation, infant formula, tobacco products and food.
may have received the product. Once the all accounts have The FDA also has discretion to order a mandatory recall if
been informed about the recall, they must promptly follow it finds that a human cell, tissue or cellular or tissue-based
the recall strategy that was previously put in place for that product is a source of dangerous infection to humans or does
account. not adequately protect against communicable disease.

FDA Requested Recall Elements of a Recall
Each FDA recall follows specific timelines and procedures
In urgent situations, the FDA may request a recall. The
request is directed to the manufacturer that has the primary depending upon the circumstances. For example, each recall
responsibility for making or marketing the product. Class is initiated with a written order that states the violation,
1 category recalls are most often requested recalls. It is the product, lot and serial numbers to be recalled, and the
important to note the FDA considers an FDA requested timeline for the recall. Each recall is unique and requires
recall to be manufacturer initiated. its own recall strategy developed by the Center Recall Unit.
The CRU will consider how far the recall should extend,
The Associate Commissioner for Regulatory Affairs whether the public needs to be warned and if so, in what
approves all recall requests from the FDA. A letter outlining geographical area, and the appropriate assessment for recall
the need for a recall is sent to manufacturer. After a recall effectiveness. S
has begun, the recall is entered in the Recall Enterprise

A recall is an action taken
by a manufacturer to
remove a product from
market.

Almost all recalls are Urgent Very limited
begun as voluntary
Initiated by manufacturer Initiated by FDA due to Narrowly restricted by federal
potential harm statute
Manufacturer is responsible for
contacting users about recall Based on agency determination FDA can only order recall if it
that action is needed to protect fits within statute limitation
public health and welfare
FDA may issue public warning

VOLUNTARY & FDA REQUESTED RECALLS ARE

CONSIDERED MANUFACTURER INITIATED

All recalls are initiated with a written order citing violation, product, lot and serial numbers and timeline for recall.

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