2. RECALL
A drug recall is the most effective way to protect
the public from a defective or potentially harmful
product.
A recall is a voluntary action taken by a company
at any time to remove a defective drug product
from the market.
3. 1.Product recall committee:
Product recall committee consist of following
members-
a) Director Technical
b) Vice President - Technical
c) Head - Regulatory
d) Head- Production
e) Head -QA & QC
f) Head – Marketing
4. 2. Procedure of Product Recalls:
The objective of a recall is to discontinue
distribution, retail sale of the product and to
retrieve concerned stocks from the market.
This objective is best served by sending a suitable
communication to Company's Distributors,
Wholesalers, and the Field Staff.
5. The recalled stock shall be stored separately and
securely till the decision on further action by
recall committee is finalized.
After the batch is returned to the company, it will
be destroyed in a manner that may be decided by
the committee.
6. Head QA & QC will investigate the market
complaints, stability failure to evaluate the risk
associated and initiate product recall.
In case of directives from regulatory authorities,
the product recall will be commenced as per the
directives.
7. Head – QA & QC will decide the type of recall in
consultation with recall committee.
Head – QA & QC will communicate the decision
of product recall with product details to:
Director – Operations / Distribution Manager /
Contract Giver / Principal company, as the case
may be for effecting recall and to Chief
Executive Officer for information.
8. Recall Status Report for domestic market:
Director Operation / Distribution Manager will send a
product recall circular with time frame, immediately to
various concerned persons in distribution to return all the
stocks of product at the earliest. (As per Annexure - 1 )
He will also instruct to stop further sales of the product
of the said batch at every distribution / sales point. They
will have to be requested to reply to the company. (As
per Annexure - 2 )
9. • However, in case of urgent recalls in addition to
sending circulars immediate contact with concerned
persons should be established by telephone, fax, email
or any other available means.
• All product recall must be executed expeditiously.
• Forms as per Annexure - 2 in which replies are
requested to be obtained from distributors, stockiest. etc.,
regarding confirmation that they have returned the
products should be made available to each member of
the field in enough quantity.
10. • The progress of recall is monitored and closed by Head –
QA & QC on information of product withdrawal details.
The details are recorded in Annexure – 3.
• The returned stock statement shall be submitted FDA.
• After completion of all regulatory requirements, the
stock of returned material shall be destroyed by
appropriate method.
