3911 Drug Notifications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. xxxx-xxxx
Expiration Date: Xxxxxxx xx, 201x

Drug Notification

See PRA Statement on page 2.

Refer to instruction sheet (Form FDA 3911 Supplement) for more information.
1. Type of Report (Select one):

Initial Notification

Follow-Up Notification

Request for Termination

2. Incident Number (Provide this number, assigned by FDA, if you selected Follow-up Notification or
Request for Termination above; see instructions.)
3. Date of Initial Notification (mm/dd/yyyy)

4. Date Company Determined Product Was
Illegitimate (mm/dd/yyyy)

5. Classification of Notification (Select
from list)

Description of Product
6. Name of Product as It Appears on Label

7. Primary Ingredients(s) (if known)

8. Drug Use (Select from list)

9. Drug Description (Select from list)

10. Strength of Drug

11. Dosage Form (Select from list)

12. Quantity of Drug (Number and Unit)

13. NDC Number (if applicable)

14. Serial Number (if applicable)

15. Lot Number(s)

16. Expiration Date(s)

17. For Notification: Description of Event/Issue

Add Page for Item 17

18. For Request for Termination of Notification: Description of why notification is no longer necessary

Add Page for Item 18

19. If you have submitted information to FDA through an alternative mechanism, check all that apply.
BPDR

MedWatch 3500

None

FAR

MedWatch 3500A

Other (Specify):

FORM FDA 3911 (8/15)

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PSC Publishing Services (301) 443-6740

EF

Company/Facility Information
20. Company Name & Address
Name
Address 1 (Street address, P.O. box, etc.)
Address 2 (Apartment, suite, unit, building, floor, etc.)
City

State/Province/Region

Country

ZIP or Postal Code

21. Company Category (Select from list)

22. Unique Facility Identifier (of company named in #20)

23. Contact Information (Note: For the telephone, you may enter the number of either the contact person or of the company named in #20.)
Name

Telephone Number (Include area code)

Email Address

SUBMIT BY EMAIL

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 1 hour per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[email protected]
“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number.”

FORM FDA 3911 (8/15)

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