Approved by FDA On 10/05/2009

MED WATCH TORRENT PHARMACEUTICALS LIMITED Mfr Report #

THE FDA MEDICAL PRODUCTS REPORTING PROGRAM UF/Importer #

Page 1 Of 1 FDA Use Only

A. PATIENT INFORMATION C. SUSPECT MEDICATION(S)

1. Patient Identifier: 2. Age at Time of Event: 3. Sex: 4. Weight: lbs 1. Name (Give labeled strength & mfr/labeler):
00000113 ( x ) Female OR #1: Levetiracetam 500 mg Tablets
OR ( ) Male ___Kgs #2: _______________
Date of Birth:

B. ADVERSE EVENT OR PRODUCT PROBLEM 2. Dose, Frequency & Route Used: 3. Therapy Dates (if unknown, give
#1: duration) from/to (or best estimate):
1. ( x )Adverse Event and/or ( )Product Problem (e.g., defects/malfunctions) #2: ___ #1: | | 4
2. Outcomes Attributed to Adverse Event (Check all that apply): #2: ___

( ) Death(mm/dd/yyyy): ( ) Disability or Permanent Damage 4. Diagnosis for Use (Indication): 5. Event Abated After Use Stopped or
#1: Dose Reduced ?:
#2: ___ #1: ( )Yes ( )No ( x )Doesn't Apply
#2: ( )Yes ( )No ( )Doesn't Apply
( ) Life-threatning ( ) Congenital Anomaly/Birth Defect 6 Batch/Lot No#: 7 Exp. Date:
#1: ghghgh #1:
#2: ___ #2: ___

( ) Hospitalization ( ) Other Serious (Important Medical Events): 9. NDC# or Unique ID 8. Event Reappeared After Reintroduction:
#1________________________ #1: ( )Yes ( )No ( x )Doesn't Apply
#2________________________ #2: ( )Yes ( )No ( )Doesn't Apply

( )Required intervention to Prevent Permanent Impairment/Damage (Devices) 10. Concomitant Medical products and Therapy Dates (Exclude treatment of event)

3. Date of Event (mm/dd/yyyy): 4. Date of This Report (mm/dd/yyyy):

06/02/2010 07/01/2010

5. Describe Event or Problem: G. ALL MANUFACTURERS

ggfgfg 1. Contact Office - Name/Address (and 2. Phone Number:

Manufacturing Site for Devices):
3. Report Source(Check all that apply)
( )Foreign
Dawn M Chitty, Director of Regulatory Affairs
( )Study
Torrent Pharma Inc.
( )Literature
5380 Holiday Terrace, Suite 40
( )Consumer
Kalamazoo MI 49009
( )Health Professional
269-544-2299
( )User Facility
( )Company Representation
( )Distributor
( )Other:

6. Relevent Tests/Laboratory Data, Including Dates: 4. Date Received by Manufacturer(mm/dd/yyyy): 5.

07/01/2010 (A)NDA #:
dfdfdfd IND #:
6. If IND, Give Protocol# NA
STN #:
7. Type of report (Check all that apply) PMA #:
( ) 5-day Combination Product: ( )Yes
( ) 7-day Pre-1938: ( )Yes
( ) 10-day OTC Product: ( )Yes
( ) 15-day
( ) 30-day
( ) Periodic
( ) Initial
( ) Follow-up:

7. Other Relevant History, Including Preexisting Medical Conditions (e.g, allergies, race, pregnancy, 8. Adverse Event term(s):
smoking and alcohol use, hepatic/renal dysfunction, etc.):

9. Manufacturer Report number:

Submission of a report does not constitute an admission that medical E. INITIAL REPORTER
FDA personnel, user facility,importer, distributor, manufacturer or product
caused or contributed to the event. 1. Name and Address
3500 A Facsimile Anonymity Requested
Add:rggfgf
Phone:9099960353

2. Health Professional ? 3. Occupation ? 4. Intial Reporter Also Sent Report to FDA

( x ) Yes ?
( )No ( ) Yes ( ) No ( x ) Unk