Company Logo Company Name & Address

Page 1 of 5

Format No.: Effective Date:

Title: Product Recall/ Withdrawal Form

1. Recall Details (To be filled by quality Assurance personnel):

Product Recall Report No. Assigned by QA
Initiation Date

Party Name

Name of Product*

Batch No.*
Mfg. Date*

Exp. Date*
Batch Size*
Manufacturing Site name and
address
Quantity Manufactured
Quantity released in market
Market
Sale / PS / CGHS / Others
Balance quantity at site
* Additional sheet shall be attached if numbers of batches to be recalled are more than one.

Reason for Recall:

Distribution / Stock statement details (attach additional sheet if required):

Returnable Quantity in stock Name of customer / distributor/ Wholesaler/
Sr. No.
statement stockiest

Total
Balance Accounted for

Attachments / Supporting Data (If any):

Initiated By Name Signature Date

 Company Logo Company Name & Address
Page 2 of 5

Format No.: Effective Date:

Title: Product Recall/ Withdrawal Form

QA

2. QA Review and Approval

Review Comments:

Classification of Recall: (Put Tick mark)

1. Class – I 2. Class – II 3. Class – III 4. Class - IV

Recall: 1. Approved 2. Rejected

The Product Recall is limited to time / Product / No. of Batches

Approved /rejected By Name Signature Date
Head-QA

3. Implementation of Product Recall (attach additional sheet if required)

Proposed Recall Plan (attach additional sheet if required):
Sr. Returnable Quantity Name of customer / distributor/ Qty.
Responsibility TCD
No. in stock statement Wholesaler/ stockiest received

Total

Balance Accounted for

Difference / Observation if any provide justification (Attach Additional Sheet If Any):

 Company Logo Company Name & Address
Page 3 of 5

Format No.: Effective Date:

Title: Product Recall/ Withdrawal Form

Data Generated (If any):

Name Signature Date

Implemented by Head-
Marketing

4. QA Review of Implementation & Closure (Attach additional sheet if required)

Summary Report of Recall / Withdrawal:

QA Comments:

Corrective and Preventive Action (If any)

Verification of Implementation of Corrective and preventive Action

 Company Logo Company Name & Address
Page 4 of 5

Format No.: Effective Date:

Title: Product Recall/ Withdrawal Form

All the recommendation fulfilled: 1. Yes 2. No

If No, Justification:

Data Generated completed: 1. Yes 2. No

If no, Justification:

Verified By Name Sign. Date

QA
5. Final decision by Head QA
1. Disposal 2. Reprocessing 3. Rework

1. Closed 2. Not Closed

Closer Comments:

Closed by Name Signature Date

Head-QA