Pharmaceutical product recall

1. By Prandeep Borah
MSF Pharmacy, GFSU

2.  Recalls are actions taken by a firm to remove a product
from the market.
 Recalls may be conducted on the basis of
 a firm's own initiative,
 by FDA request, or
 by FDA order under statutory authority.
The guidance is intended to assist those
members of industry regulated by the
Food and Drug Administration (FDA) in
handling all aspects of a product recall,
including all corrections and removals.

3.  1. Class I recalls have a reasonable probability that the use
of the product or exposure to the product will cause
serious, adverse health consequences or death.
 An example of a Class I recall is a label mix-up of two
potent drugs or a defective replacement heart valve. The
recall should include all stocks of the two drugs in
pharmacies with notification of all patients who received
the product.
 If the recall involves heart valves ,all hospitals and all
heart valve recepients would receive notification.

4.  2. Class II recalls involve products that the use of the
product or exposure to the product may cause
temporary or medically reversible health consequences
or where probability of serious harm is remote.
 An example of a Class II recall is a sub potent drug
product. The recall usually includes the stocks of drugs
in pharmacies.

5.  3. Class III recalls involve the use of or exposure to
product that is not likely to cause adverse health
consequences.
 An example of a Class III recall is inclusion of material
not intended for inclusion in the product such as dirt,
plastic, animal parts.

6.  Market withdrawal:
Occurs when a product has a minor violation that would not be
subject to FDA legal action. The firm removes the product from
the market or corrects the violation. For example, a product
removed from the market due to tampering, without evidence of
manufacturing or distribution problems, would be a market
withdrawal.
 Medical device safety alert:
Issued in situations where a medical device may present an
unreasonable risk of substantial harm. In some case, these
situations also are considered recalls.
 It is recommended to submit the information to local FDA District
Recall Coordinator as soon as possible after the decision to recall is made
not waiting to submit information until ALL applicable information is
prepared

7. Recommend to include the following information in your
recall submission
 PRODUCT INFORMATION:
Product name
Description of the product; Dosage form, indication
 TWO COMPLETE SETS OF ALL Product labeling
Individual package label
Package Inserts
 CODES (Production Identification Numbers):
* Lot/Unit Numbers

8.  RECALLING FIRM:
Firm name, address
CONTACTS for Recalling Firm: Name/title/phone/fax
number/e-mail
 MANUFACTURER:
* Firm name, address, city, state, zip code
* FDA registration number
 REASON FOR THE RECALL:
Explain in detail how product is defective and/or violative.
 Explain how the defect affects the performance and safety of
the product

9.  If the recall is due to the presence of a contaminant (cleaning fluid,
machine oil, paint), explain level of contaminant in the product.
 If the recall is due to failure of the product to meet product
specifications, provide the specifications and report all test results.
Provide copies of any sample analysis.
 If the recall is due to a label/ingredient issue, provide correct and
incorrect labels.
 Please explain how the problem occurred and the date (s) it
occurred.
 Explain how the problem was discovered and the date discovered.
 Provide detailed information on complaints associated with the
product.

10.  HEALTH HAZARD ASSESSMENT
 VOLUME OF RECALLED PRODUCT
Total quantity produced ;
Date (s) produced ;
Quantity distributed
Estimate amount remaining in marketplace
distributor level ;retail ;user level
 DISTRIBUTION PATTERN :
wholesalers/distributors ; repackers
manufacturers ; retail/pharmacy ;foreign consignees
 Provide a consignee list (names/address/city/state/contact
name/phone number) to the local District Recall Coordinator

11.  RECALL STRATEGY:
Indicate the level in the distribution chain to which you
are extending the recall. (i.e. wholesale/retail.)
Indicate the method of notification (i.e. mail, phone,
facsimile, e-mail).
Indicate how letters will be sent to customers .
Report on what you have instructed customers to do
with the recalled product .
Report on recall effectiveness check strategy.

12.  Public Notification
In a situation where the product may pose a significant health
hazard and recalled product is in the hands of consumers, a
press release is usually appropriate. Include the following
information in a recall notification
 PRODUCT IDENTIFICATION:
DESCRIPTION OF THE PROBLEM: codes used to identify
the product, e.g. lot/unit numbers
 DEPTH OF THE RECALL:
The recall notification should clearly identify the depth to
which the recall is to extend (e.g. wholesale, retail, or user
level

13.  INSTRUCTIONS TO CUSTOMERS
 EFFECTIVENESS OF THE RECALL:
It is the recalling firm’s responsibility to assure that the recall
is effective. Therefore, we recommend that you consider
effectiveness checks for every recall.
 RECALL STATUS REPORTS: to your local District Recall
Coordinator
 ROOT CAUSE OF THE PROBLEM THAT RESULTED IN
THE RECALL:
 CORRECTIVE ACTIONS TO PREVENT FUTURE
OCCURRENCES OF THE PROBLEM:

14. In the fall of 1982, seven
people in the Chicago area
died after ingesting Extra-
Strength Tylenol laced with
potassium cyanide. Sparked a
citywide panic; for days,
police cruised the streets,
blaring warnings that
residents should discard the
product.
Johnson & Johnson spent
millions of dollars recalling
Tylenol from stores
nationwide.

15. THANK YOU