What is Recall in Pharmaceutical Industry? Procedure involved in Product Recall

Product Recall means any action/procedure taken by the manufacturer, importer, marketer, supplier or registrant or enlistment holder of a product to remove it from the market or to retrieve from any person to whom it has been supplied because of the reason that the product;-

  • may be hazardous to health; or/and
  • may fail to conform to any claim made by its manufacturer, importer, registrant or enlistment holder relating to the quality, safety, efficacy or its usefulness; or/and
  • may not meet to the Quality Requirements;

Factors affecting Product Recall:

A pharmaceutical product may be recall from many reason as discussed above and other than discussed above. Due to complex distribution system and time taken process, 100% product recall from market is not possible. How much product will be received back depend at many factors like:

  • Time duration between manufacturing of batch and recall of product
  • Batch Size of Product recall
  • Nature of Product i.e. OTC, Prescription etc
  • Number of persons involves in Distribution Channel
  • Demand and Supply Ratio of Product (Consumption of Product)
  • Coverage Area of Product
  • Transportation Facilities, Time and Expanses during Recall
  • Expiry Date of Product

Types of Product Recall:

  • Voluntary
  • Requested by Authorities

Voluntary Product Recall:

If Product’s Manufacturer, importer, marketer, supplier or any other person involved in product distribution channel recall the product by itself  by finding product of inferior quality in re-checking, re-testing or any other way then it is Known as Voluntary Product Recall.

Requested by Concern Drug Authority:

If any Government Authority at concerned country responsible for pharmaceutical products standards and quality measures, finds product is not of standard quality (Failing of samples taken time by time) may request to concern person, institute or organisation to recall that product from market in Public interest. In case concern person, institute or organisation don’t recall product at concern authority then concern authority may use its power to recall or force manufacturer or any other concern person to recall that product from market    

Procedure of Product Recall:

When a product is identified as of inferior quality or not of required standards, a product is recalled by its manufacturer, importer, marketer, supplier or any person involved into distribution channel. A product recall procedure involve following steps:

Step 1: In case of product recalled on request by Authority, Authority issue a letter confirming that product found of inferior quality or may not comply with standards as prescribed to the manufacturer, importer, marketer, supplier or any person involved into distribution channel. Involved person has to reply this letter at specific period of time. This letter may contains other required documents or details by drug authorities. Generally this letter asking the details as follow:

  • Confirmation of supply to whom sample taken
  • Source from where you obtained product (If you are not manufacturer)
  • Detailed Distribution report of that product along with invoice number, date and quantity
  • Issuing Recall letter to concern persons to whom you supply that product
  • Stock present at you
  • Attached list of test report issued by Authority Laboratory confirming found specification during testing
  • Any other detail if required 

In case of Voluntary Recall this step doesn’t involve. Internal test laboratory or any other laboratory confirms about product inferiority or lack of specific standards and starts recall procedure itself.

Step 2: Receiver has to reply the letter issued by concern drug authorities and Issue Recall Letter to all concern persons, firms, institutions or organisations to whom product has been supplied.

If you are a Pharmacy, then mention source of product as distributor or Stockist. Your customers to whom you supplied will be patients. If you are a Distributor or stockist then mention source of product as C&F or Manufacturer or Marketer or Importer. Distribution report will include all pharmacies chemist/retailers.

If you are Carrying and Forwarding Agent (CNF) then mention source of product as Manufacturer or Marketer or Importer. Distribution list will include Distributors and Stockist detail. Marketing Companies or Importers will have to mention manufacturers from which to get manufactured or imported that product.

Its Distribution report will include CNF or Stockist or Distributors. Manufacturer has to submit his own Certificate of Analysis reports and other testing quality procedure details carries during manufacturing of that product. And distribution report.

Step 3: A Recall letter has been issued by Manufacturer, importer, marketer or any other concern person. A manufacturer will issue Recall letter to CNF or Marketer or Importer. A CNF or Marketer or Importer will issue recall letter to Distributors or Stockists or CNF.

A Distributor or Stockist will issue Recall Letter to Pharmacies/Retailers/Chemist. Further Pharmacy/Chemist may ask for return of product to patients but it’s practically not possible. Either patient may have consume it or it is difficult to locate patient easily.   

Step 4: Receiving of Recalled Stock and Destroyed by Manufacturer in presence of Concern Authorities.

hope above information is helpful to you…

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