Products are recalled when they violate the laws given by authorities like Food and Drug Administration. The given article deals with procedure for recalling of product.
1.0 Introduction
FDA regulations, sub part C of part & gives the guidance for the recall of product either voluntary recall or by a firm.
1.1 Submission
For recalling a product the following need to be submitted
i) Product information
Name of the product – brand / generic
Order number or catalogue, model
Product description – dosage form, indications, shelf life, packaging (box, glass or plastic)
Labeling – product labelling with all private labels, individual package label, package inserts, case label, directions on usage, promotional material
Additional information (Drug Recall)
NDA or ANDA or NADA number
NDC number
Prescription indication or OTC
Route of Administration
Strength
Additional information (Medical device recall)
PMA number or IDE or 510 (k)
Additional information (Biological recall)
Registration number
License number
ii) Codes – Production identification number
UPC codes
Expiration date or expected shelf life or Use by date
Serial number – Medical devices
Lot or unit numbers
iii) Recalling firm
Firm name, contact details – address, zip code, city, state
Firm type – manufacture or import or broker or distributor or repacker
Contacts for recalling firm
Name or Phone number or email address or fax number for contacting
Name or Phone number or email address or fax number of the person responsible for recalling firm
Name or Phone number or email address or fax number for public contact
iv) Manufacturer
Name, contact details - address, zip code, city, state of the firm
FDA registration number (if applicable)
v) Firm responsible for problem or violation
Name, contact details - address, zip code, city, state of the firm
vi) Recall reason
Description of violation or defective product
Detailed explanation on the impact of defect on safety and performance of the product
If the recall is due to foreign object, explain the foreign object – its size, hardness, composition and sharpness
If the recall is due to contaminant, explain the level of contaminant in product along with labeling, ingredients list and material safety data sheet
If the recall is due to failure to meet specifications then provide the specifications, test results and sample analysis copies
If the recall is due to label or ingredient then identify the incorrect labels, formulations and descriptions
Note the date problem occurred and how it occurred
Detail about the discovery of problem and the date it was discovered
Detail whether a portion of units or all units are recalled
Detail on how the problem impacts the products or lots recalled
Information should be provided on the following along with the complaint
Complaint date
Serial number or lot number
Complaint description – details of any illness or injury
In case of Medical device complaints – Copies of MDRS- Medwatch
Identify the agency and contact when state agency is involved
Drug recalls for products of NDA or ANDA or NADA or ANADA – details on Field alert
vii) Assessing Health Hazard
Detail on assessment of risk associated with deficiency
If the recalled product is a biological product – blood product or human tissue, due to viral marker testing or donor suitability then copy of following should be given
Donor screening form
SOPs – acceptance criteria
Test results (if available - confirmatory results)
viii) Volume of product recalled
Total quantity produced
Date on which it is produced
Distributed quantity and date on which it is distributed
Quantity under HOLD by recalled firm and distribution centers
Details on how the product is under quarantine
Estimate the remaining amount in market place at retail level, distributor level, pharmacy level and user level
Give the status of the marketed product whether it is used or destroyed
xi) Distribution
Number of direct accounts – customers to whom the product is directly sold
Wholesalers or distributors
Retail or veterinarian or pharmacy
Repackers
Users – hospitals or clinics or labs
Consumers – catalog sales or by internet
Government consignees
Foreign consignees
Geographic area for distribution – foreign countries
Consignee list along with their contact details - address, zip code, city, state
Consignee list indicates the customers to whom the recalled product is shipped
If the product is sold under government contract then contract number, date and implementation date should be given
If the product is sold to federal, state or local agency then list the consignees with quantity, sale and shipped date
Ship to is given to customers to retrieve the product from their location
Bill to is given to customers to initiate sub recall
x) Recall strategy
Indicate the distribution chain level i.e. wholesale or pharmacy or user level
Indicate the notification method and have a record of the same
Indicate the mode of communication to inform the customers by letters –overnight mail, certified mail, First class mail or facsimile
If the initial notification is by phone then provide phone script to the FDA
If website is available then recall notification can be posted
Report on the instructions that customer needs to follow
Name and title of recall contact for every consignees
If product needs to be returned then explain the process
Explain if any shortage occurs in the market due to recall and how it will impact the customer
Report on recall effectiveness check strategy
Provide the course of action for out of business distributors
Indicate the method of destruction
If the product is to be reconditioned explain how and where the reconditioning should take place. The reconditioning plan should be given to FDA district recall coordinator before implementing.
Detail on how to identify the reconditioned product and not confused with the recalled product
Other considerations
Contact the FDA district coordinator for recall before destroying the product
Documentation should be maintained regarding the product destruction by the customers & recalling firm
Any field corrections such as product relabeling are to be done by representatives of recalling firm
Before release of the reconditioned goods local district recall coordinator should be contacted
1.2 Public Notification
1.2.1 Press release
A press release is the best way indicating the goods may pose risk to the patient’s health and it should be issued promptly
Before issuing a press release district recall coordinator should be consulted. A joint press release where the firm and FDA issue press release where the public can be alerted regarding the issue.
1.2.2 Recall notification
The following should be followed while writing notification letters
Recall notifications should be flagged in large bold letters as in “URGENT: [insert “FOOD”, “DRUG”, “MEDICAL DEVICE”, etc.] RECALL or CORRECTION”
Envelopes should also be flagged
i) Product identification
Product description and codes to identify like serial numbers or expiry dates
Copy of product label with recall notification which helps in identifying and removing recalled product by wholesalers and retailers
ii) Problem description
Problem and the hazards associated with it should be identified
iii) Extent of Recall
The notification should identify the extent of recall. If the recall is at retail level then it should be given as “This recall is to the retail level”
If the product is at user level then the instructions for subrecall should be included. This should also include the extent of the problem like “if you have further distributed this product, you should notify your customers to the retail level”.
The date range for the recalled product should be given in the notification so it helps in easy identification
Subrecall letter should be given along with notification package to notify their subaccounts which are complete and accurate
vi) Instructions
The instructions should be clear like cease distribution or return product or remove product from sale etc.
Return response card should be included which includes the instructions from recall letter.
All customers in the distribution chain should be informed of the recall
1.3 Evaluation of recall
1.3.1 Recall Effectiveness
Recalling firm should take the responsibility to ensure the effectiveness of the recall. Recalling firm should ensure that notification letter is received by the customer.
Effectiveness should be checked by verifying the recall is reached to appropriate level in the distribution chain
If the recall is not received by the customer then taken necessary steps to make it effective like follow up notification on identifying product or explaining the problem
1.3.2 Reports
After initiating recall reports are to be provided to local district coordinator for recall. They should include information like
Date of notification
Number of customers notified and responding
Quantity of recalled product accounted or recalled
Details of evaluating effectiveness
1.3.3 Root cause
After the root cause of the recall is established then it should be notified to local district coordinator. This helps in finding the preventive measures
1.3.4 Corrective action
Corrective actions should be indicated to prevent the problem from reoccurring and it should be notified to local district coordinator.
1.3.5 Termination of recall
Recall should be evaluated for termination when customer responses have been received and corrected. Final status report should be prepared and documented and should be provided to local district coordinator.
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