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SOP 10 (Version Number 1) Supersedes: N/A

TITLE: Product Recall Emergency Plan

SOP No: 10 Written By: Donncha Kearney
Version No: 1 Date of Preparation: 01/03/16
Supersedes: N/A Approved By:
Date of Issue: Date of Approval:

Document History:

1. First Issue: 01/03/2016

2. Reviewed: Every 6 months

INTRODUCTION

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Outlined in this document is the process Ballybane Pharmacy must adhere to

when they receive notice that a product must be recalled.

PURPOSE
Public safety is of the utmost important, and so every product recall must be
dealt with in the most efficient, timely manner possible. In the event of a product
recall, it must be dealt with immediately, as soon as the Pharmacy is notified.

SCOPE
Trained Staff Members will be responsible for product recalls. Product recalls are
the ultimate responsibility of the Responsible Pharmacist.

POLICY
All product recalls are dealt with immediately, in a safe and efficient manner as
quickly as possible.

FREQUENCY
Every time a Product Recall Notification is received by Ballybane Pharmacy.

DOCUMENTATION
Goods Return Note/Medicinal Product Recall Log (Appendx 10/01); Medicinal
Recall Record (Appendix 10/02).

STAFF
Only Staff Members who have been trained and the Responsible Pharmacist can
deal with product recalls.

PROCEDURE
DEFINITION: Product Recall

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The process of retrieving defective goods from consumers to ensure that

no harm comes to the public. Recalls often occur as a result of safety
concerns over a manufacturing defect in a product that may harm its user.

When Ballybane Pharmacy received a product recall, the Responsible

Pharmacist must be contacted immediately. If the RP is not available, a
trained Staff Member must carry out the initial processing to ensure public
safety.

RECALL FROM A MANUFACTURER, WHOLESALE, HPRA OR HEALTH

BOARD
1. Once a recall is received from the Pharmacy, the Staff must determine the
class of recall, and react according to the scale. The Caution of Use
notification does not warrant a recall, but healthcare professionals must be
informed of the details of the defect.

Recall classes are detailed as follows:

Class I Class II Class III Caution in

Use
Notifcation
Recall Within 24 Within 72 Within 5 days Within 5 days

Classificati hours hours

on
Notification
Period
Method of Phone & Fax, Phone (if Wholesaler, Pharmacises,

Notification Radio/TV (if necessary), possibly possibly

necessary), followed by pharmacies medical
Press Fax/Letter and other practitioners,
Announcemen retail outlets possibly
ts wholesalers
Extent of Wholesalers, Wholesalers, Wholesalers, Pharmacies,
pharmacies, pharmacies, possibly possibly

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Notification other medical hospitals, pharmacies medical

practitioners possible and other practitioners,
and doctor/dentist retail outlets possibly
professional or wholesalers
groups, veterinarian
patients, other level, possibly
retailers other retail
outlets
Method of Direct uplift of Via wholesaler Via wholesaler Not applicable

Retrieval of stock

Recalled
Stock

RECALL INITIATED BY SUPPLIER, HPRA, PA HOLDER OR

MANUFACTURER
1. On receipt of notice from any of the above, the Staff Member must obtain
all possible details of the suspected product:
- Product name;
- Product strength;
- Product form;
- Batch number;
- PA number;
- Expiry date;
- Quantity to return;
- Reason for recall.

2. Remove all suspect products from the Pharmacy stock by initiating a visual
check and segregating items from the remaining stock. Items should be
placed in the quarantine area, wrapped and clearly labelled as Recall
Stock.

3. Initiate the check from the Goods Inwards Record to identify customer(s)
who were supplied with the suspect stock, and check the date on which
they were supplied. Request these customer(s) to visually check their
stock, ensuring they have the relevant details, then instruct them to put
aside the remaining items for uplifting. The Pharmacy should discontinue
issuing the suspect product. Written confirmation of the report will be sent
as soon as possible.

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4.

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