A drug recall is the removal of hazardous drugs from distribution due to issues related to quality, efficacy, or safety, including adverse reactions and defects. Recalls can be voluntary or statutory and are classified into three classes based on severity, with specific procedures for execution. Key reasons for recalls include regulatory noncompliance, consumer complaints, and ongoing testing results.

1. DRUG
RECALL

2. Recall is an action taken to
withdraw/remove the drugs from
distribution or use including
corrective action for which
deficiencies are reported in quality ,
efficacy or safety .
The defective products related to
quality includes No of Standard
Quality, Adulterated or Spurious
drugs.
Safety and efficacy related recalls
include serious adverse reactions
and death.
DEFINITION

3. REASONS FOR RECALL
Customer complaints
Detection of GMP failure after release
Result from the ongoing testing
Result of an inspection
Adverse reaction reporting

4. TYPES OF RECALL
VOLUNTARY RECALL
 If the batch or batches are found to be noncompliance
with the regulatory specifications during the post-
marketing studies.
 If the batch is found to be defective which it is
finding out from market complaint.
 If any unusual observation is founded during a visual
inspection of retention samples which indicate an
impact on the quality of the product after
investigation.
 If the pharmacovigilance reports indicate that there is
a serious risk associated with the product.
STATUTORY RECALL
 To recall the drug product/ batch., if they are out of
standard quality etc.
 To recall the banned drugs
 Labelling and/or Promotional materials, that are
considered to be in violation of the law.

5. CLASS-I
CLASS-II
CLASS-III
S
E
V
E
R
I
T
Y
Severe Health Problems or Death
Temporary Health Problems or Pose
slight Threat of Serious Nature
Unlikely to cause any Adverse
Health Reaction
DRUG RECALL CLASSIFICATION

6. EFFECTIVE TIME PEROID FOR RECALL
CLASS-II
Started within 48 hours

7. LEVELS OF RECALL
CONSUMER
OR USER
LEVEL
RETAIL
LEVEL
WHOLESALE
LEVEL

8. RECALL PROCEDURE

9. REFERENCES
 https://www.researchgate.net/publication/342199902_An_Ove
rview_on_Pharmaceutical_Drug_Recalls
 http://www.slideshare.net/AhmedSuhail11/recall-of-ph-
product-122238516?from_m_app=android

10. THANK YOU
BOLLAM.SARIKA -007/0122
bollamsarika@gmail.com