Recall

Question 1

Talk me through how you would recall?

Answer 1

Perform an Initial investigation
Block / Quarantine all stock within company control / Stop Release and Manufacturing Activities
Determination of all other stock locations - inform third parties to put stock on hold – RECONCILIATION NEEDS TO BE 100%
Call / Email DMRC

Question 2

In a recall situation what information would you present to the DMRC?

Answer 2

Contact the DMRC and provide as much information as is available, including:
Name, position, organisation and telephone contact of the person reporting the
issue;
Manufacturer/Supplier;
Product licence number(s);
Type of market action (recall or market withdrawal)
Product name(s), and strength (include brand name and generic name):
NDC number or product identification number
Description of product (dosage form, intended use)
Containers and package size
Lot numbers and expiry dates, distributed qty., dates of distribution
Stock level within the distribution chain and quantity on the market;
Potential impact that recall action may have on the availability of product to the market.
Product labelling
Reason for recall
Conclusion of health hazard assessment / medical risk assessment
Recall level and strategy
Recalling firm and contact details
Manufacturer site address

Question 3

Who can make the decision to recall? Who would you get involved?

Answer 3

Head of Quality / Qualified Person on behalf of the MA Holder
Senior Management, Head of Production and QC
QPPV
Medical Department