> ![](media/image1.png){width="0.7805555555555556in"
> height="0.8048611111111111in"}**DEPARTMENT OF HEALTH AND HUMAN
> SERVICES** Public Health Service
>
> Food and Drug Administration
>
> Rockville, MD 20857
>
> Dear Application Holder:
>
> The attached report form is being furnished for your convenience in
> complying with the \"NDA- Field\
> Alert\" reporting requirements of Section 314.81 (b)(1)(i) and (ii),
> as codified in Title 21 of the Code\
> of Federal Regulations, effective May 23, 1985:
>
> \"314.81 Other postmarketing reports.
>
> \(a\) Applicability. Each applicant shall make the reports for each of
> its approved applications and\
> abbreviated applications required under this section and sections 505
> (j) and 507 (g) of the act.
>
> \(b\) Reporting Requirements. The applicant shall submit to the Food
> and Drug Administration at\
> the specified times two copies of the following reports:
>
> \(1\) NDA-Field Alert Report. The applicant shall submit information
> of the following kinds about\
> distributed drug products and articles to the FDA District office that
> is responsible for the facility\
> involved within three working days of receipt by the applicant. The
> information may be provided\
> by telephone or other rapid communication means, with prompt written
> followup. The report and\
> its mailing cover should be plainly marked: 'FDA-Field Alert Report.'
>
> \(i\) Information concerning any incident that causes the drug product
> or its labeling to be\
> mistaken for, or applied to, another article.
>
> \(ii\) Information concerning any bacteriological contamination, or
> any significant chemical,\
> physical, or other change or deterioration in the distributed drug
> product, or any failure of one or\
> more distributed batches of the drug product to meet the
> specifications established for it in the\
> application.\"
>
> In this context, PLEASE NOTE that the information required under 21
> CFR 314.81 *SHOULD NOT\
> *be submitted with reports of adverse drug reactions as described
> under 21 CFR 314.80, the regulation\
> dealing with the postmarketing reporting of adverse drug experiences.
>
> Accordingly, please submit the required *21 CFR 314.81* information
> within three (3) working days to\
> the \"NDA-Field Alert Report\" coordinator in your jurisdictional FDA
> District Office, who will also be available to answer any questions
> that you may have regarding your reports.
>
> For your convenience, the addresses and telephone numbers of all FDA
> district offices are listed on\
> the reverse side.

### FDA/ORA FIELD ADDRESSES

New York District (NYK-DO)\
158-15 Liberty Ave.\
Jamaica, NY 11433\
Tel: 718-340-7000

New England District\
(NWE-DO)\
One Montvale Ave., 4th Floor\
Stoneham, MA 02180\
Tel: 781-596-7700

Buffalo Branch (NYK-DO)\
300 Pearl St., Suite 100\
Buffalo, NY 14202\
Tel: 716-551-4461

Philadelphia District (PHI-DO)\
900 U.S. Customhouse\
2nd & Chestnut Sts.\
Philadelphia, PA 19106\
Tel: 215-597-4390

Baltimore District (BLT-DO)\
6000 Metro Dr., Suite 101\
Baltimore, MD 21215\
Tel: 410-779-5454

New Jersey District (NWJ-DO)\
Waterview Corporate Center\
10 Waterview Blvd., 3rd Floor\
Parsippany, NJ 07054\
Tel: 973-526-6015

Cincinnati District (CIN-DO)\
6751 Steger Dr.\
Cincinnati, OH 45237-3097\
Tel: 513-679-2700

Chicago District (CHI-DO)\
550 W. Jackson Blvd.\
15th Floor\
Chicago, IL 60661\
Tel: 312-353-5863

Detroit District (DET-DO)\
300 River Pl. Drive, Suite 5900\
Detroit, MI 48207-3179\
Tel: 313-393-8100

Minneapolis District (MIN-DO)\
212 Third Ave. South

Minneapolis, MN 55401\
Tel: 612-334-4100

Atlanta District (ATL-DO)\
60 Eighth St., NE\
Atlanta, GA 30309\
Tel: 404-347-3151 (ATL-DO)\
704-344-6116 (Charlotte, R.P.)

Nashville Branch (NOL-DO)\
297 Plus Park Blvd.\
Nashville, TN 37217\
Tel: 615-781-5392

NOL-DO has temporarily\
relocated to the Nashville\
Branch due to Hurricane Katrina.\
Send DQRS/Field Alerts to:\
USFDA NOL-DO\
Nashville, TN 37217-1003\
Tel: 615-695-4654

Florida District (FLA-DO)\
555 Winderley Place\
Suite 500\
Maitland, FL 32751\
Tel: 407-475-4700

San Juan District (SJN-DO)\
466 Fernandez Juncos Ave.\
San Juan, PR 00901-3223\
Tel: 787-474-9500

Dallas District (DAL-DO)\
4040 North Central Expswy.\
Suite 300\
Dallas, TX 75204\
Tel: 214-253-5200

Denver Federal Center 6th\
Avenue & Kipling Street PO Box\
25087 Building 20 (Entrance\
W10) Denver, CO 80225\
Tel: 303-236-3087

Kansas City District (KAN-DO)\
11630 W. 80th Street\
Lenexa, KS 66214-3340\
Tel: 913-752-2446

San Francisco District\
(SAN-DO)\
1431 Harbor Bay Parkway\
Alameda, CA 94502-7070\
Tel: 510-337-6846

Seattle District (SEA-DO)\
22201 23rd Dr., SE\
Bothell, WA 98021-4421\
Tel: 425-483-4971

Los Angeles District (LOS-DO)\
19900 MacArthur Blvd.\
Suite 300\
Irvine, CA 92612-2445\
Tel: 949-798-7600

+-----------------------------------+--------+-----+------------------+
|                                   | Form   |     |                  |
|                                   | App    |     |                  |
|                                   | roved: |     |                  |
|                                   | OMB    |     |                  |
|                                   | No.    |     |                  |
|                                   | 0910   |     |                  |
|                                   | -0001. |     |                  |
|                                   | Expi   |     |                  |
|                                   | ration |     |                  |
|                                   | Date:  |     |                  |
|                                   | May    |     |                  |
|                                   | 31,    |     |                  |
|                                   | 2008   |     |                  |
|                                   |        |     |                  |
|                                   | See    |     |                  |
|                                   | OMB    |     |                  |
|                                   | Sta    |     |                  |
|                                   | tement |     |                  |
|                                   | on     |     |                  |
|                                   | Re     |     |                  |
|                                   | verse. |     |                  |
+-----------------------------------+--------+-----+------------------+
| DEPARTMENT OF HEALTH AND HUMAN    | TO:    |     |                  |
| SERVICES\                         | *(NAME |     |                  |
| FOOD AND DRUG ADMINISTRATION      | AND    |     |                  |
|                                   | A      |     |                  |
| #### NDA-FIELD ALERT REPORT       | DDRESS |     |                  |
|                                   | OF     |     |                  |
|                                   | DIST   |     |                  |
|                                   | RICT)* |     |                  |
|                                   |        |     |                  |
|                                   |        |     |                  |
+-----------------------------------+--------+-----+------------------+
| TYPE OF REPORT                    |        |     |                  |
|                                   |        |     |                  |
| Initial Follow-Up Final           |        |     |                  |
+-----------------------------------+--------+-----+------------------+
| In accordance with Section 314.81 |        |     |                  |
| (b)(1)(i) and (ii) of the New     |        |     |                  |
| Drug Application Regulations (21  |        |     |                  |
| CFR 314) promulgated under the    |        |     |                  |
| Federal Food, Drug and Cosmetic   |        |     |                  |
| Act, as amended, the following    |        |     |                  |
| information is herewith           |        |     |                  |
| submitted:                        |        |     |                  |
+-----------------------------------+--------+-----+------------------+
| 1\. NDA/ANDA - ANTIBIOTIC FORM    |        |     | > 2\. NDC No.    |
| 5/6 NO.                           |        |     | >                |
|                                   |        |     | >                |
| >                                 |        |     |                  |
+-----------------------------------+--------+-----+------------------+
| 3\. GENERIC NAME OF DRUG PRODUCT  | 4\.    |     |                  |
|                                   | TRADE  |     |                  |
| >                                 | NAME   |     |                  |
|                                   | *(if   |     |                  |
|                                   | any)*  |     |                  |
|                                   | OF     |     |                  |
|                                   | DRUG   |     |                  |
|                                   | P      |     |                  |
|                                   | RODUCT |     |                  |
|                                   |        |     |                  |
|                                   | >      |     |                  |
|                                   |        |     |                  |
+-----------------------------------+--------+-----+------------------+
| 5\. FIRM NAME AND ADDRESS WHERE   |        |     | 6\. FEI          |
| PROBLEM OCCURRED                  |        |     |                  |
|                                   |        |     | >                |
| >                                 |        |     |                  |
+-----------------------------------+--------+-----+------------------+
| 7\. DOSAGE FORM, STRENGTH AND     |        |     |                  |
| PACKAGE SIZE(S)                   |        |     |                  |
|                                   |        |     |                  |
| >                                 |        |     |                  |
+-----------------------------------+--------+-----+------------------+
| 8\. LOT NUMBER(S)                 |        |     |                  |
|                                   |        |     |                  |
| >                                 |        |     |                  |
+-----------------------------------+--------+-----+------------------+
| 9\. EXPIRATION DATE(S) OF DRUG    |        |     |                  |
| PRODUCTS                          |        |     |                  |
|                                   |        |     |                  |
| >                                 |        |     |                  |
+-----------------------------------+--------+-----+------------------+
| 10\. DATE WHEN NOTIFIED ABOUT     |        |     |                  |
| PROBLEM(S) OR WHEN PROBLEM(S)     |        |     |                  |
| FIRST BECAME KNOWN TO APPLICATION |        |     |                  |
| HOLDER                            |        |     |                  |
|                                   |        |     |                  |
| >                                 |        |     |                  |
+-----------------------------------+--------+-----+------------------+
| 11\. HOW WAS PROBLEM DISCOVERED   |        |     |                  |
|                                   |        |     |                  |
| >                                 |        |     |                  |
+-----------------------------------+--------+-----+------------------+
| 12\. STATE PROBLEM(S)             |        |     |                  |
|                                   |        |     |                  |
| >                                 |        |     |                  |
+-----------------------------------+--------+-----+------------------+
| 13\. PROBABLE CAUSE(S) OF         |        |     |                  |
| PROBLEM(S)                        |        |     |                  |
|                                   |        |     |                  |
| >                                 |        |     |                  |
+-----------------------------------+--------+-----+------------------+
| 14\. CORRECTIVE ACTION(S) TAKEN   |        |     |                  |
| *(if any)* TO PREVENT RECURRENCE  |        |     |                  |
| OF PROBLEM(S)                     |        |     |                  |
|                                   |        |     |                  |
| >                                 |        |     |                  |
+-----------------------------------+--------+-----+------------------+
| 15\. REMARKS                      |        |     |                  |
|                                   |        |     |                  |
| >                                 |        |     |                  |
+-----------------------------------+--------+-----+------------------+
| **NOTE:** SEPARATE NARRATIVE      |        |     |                  |
| REPORTS MAY BE ATTACHED IF        |        |     |                  |
| DESIRED.                          |        |     |                  |
+-----------------------------------+--------+-----+------------------+
| ##### REPORTING ESTABLISHMENT     |        |     |                  |
+-----------------------------------+--------+-----+------------------+
| ##### NAME AND MAI                |        |     |                  |
| LING ADDRESS *(Include ZIP Code)* |        |     |                  |
|                                   |        |     |                  |
|                                   |        |     |                  |
+-----------------------------------+--------+-----+------------------+
| ##### NAME AND T                  |        | #   |                  |
| ITLE OF AUTHORIZED REPRESENTATIVE |        | ### |                  |
|                                   |        | # T |                  |
|                                   |        | ELE |                  |
|                                   |        | PHO |                  |
|                                   |        | NE  |                  |
|                                   |        | *(I |                  |
|                                   |        | ncl |                  |
|                                   |        | ude |                  |
|                                   |        |  Ar |                  |
|                                   |        | ea  |                  |
|                                   |        | Cod |                  |
|                                   |        | e)* |                  |
|                                   |        |     |                  |
|                                   |        |     |                  |
|                                   |        |     |                  |
+-----------------------------------+--------+-----+------------------+
| ##### SIGNA                       |        | ##  |                  |
| TURE OF AUTHORIZED REPRESENTATIVE |        | ### |                  |
|                                   |        |  DA |                  |
|                                   |        | TE  |                  |
|                                   |        | SUB |                  |
|                                   |        | MIT |                  |
|                                   |        | TED |                  |
|                                   |        |     |                  |
|                                   |        |     |                  |
|                                   |        |     |                  |
+-----------------------------------+--------+-----+------------------+

**FARS FORM INSTUCTIONS**

Please fill in the location to which the form will be submitted. See
Appendix for list of FDA district office addresses.

Place check in the box which indicates whether the report is an initial,
follow-up or final report. If the report is solely an initial\
report -- please place the estimated time the final report will be
submitted in the remarks section (15). If the report is an initial\
and final report i.e., no further submission to FDA is contemplated -
check both boxes. If the report is a follow-up or final\
report - please place the date of the initial report in the remarks
section (15).

Enter the following information:

\(1\) A/NDA of the drug product involved. A/NDA numbers should match
those at www.fda.gov/cder/ob/default.htm.

\(2\) NDC number of the product(s) involved. This includes the labeler
code, product code, and if appropriate the package\
code. (For prescription drugs, valid NDC numbers may be found at
www.fda.gov/cder/ndc.) If the product does not\
have an NDC number please enter "None" and explain why in the remarks
section (15).

\(3\) Generic name of product(s).

\(4\) Trade name of product(s).

\(5\) Name and physical address of the firm where the problem occurred,
For example, if the problem occurred at a labeling\
site or repacking site, list that site here. For problems involving
stability, place the site of the product manufacturer. If\
the problem involves the bulk active pharmaceutical ingredient (API),
supply the name and complete address of the\
bulk supplier. If the site is a foreign location, include the country
name.

\(6\) Firm Establishment Identification (FEI) number of the site listed
in (5). If the FEI number is unknown, leave blank.

\(7\) Dosage form of product (www.fda.gov/cder/ndc/tbldosag.txt),
strength of product(s) in appropriate units\
(www.fda.gov/cder/ndc/tblunit.txt ), and package size(s).

\(8\) Lot number(s) of product(s) involved.

\(9\) Expiration date(s) of product(s).

\(10\) Date of discovery/notification of problem by applicant.

\(11\) Description of how the problem was discovered, e.g., routine
product testing, consumer report, etc.

\(12\) Nature of problem identified.

\(13\) Probable cause of problem.

\(14\) Corrective actions taken to prevent the recurrence of the problem
or remove the product from the marketplace.

\(15\) Remarks pertinent to FARS report or underlying issue.

Reporting Establishment section - Enter name, address, responsible
person, and submission date of the report. Please\
include the relationship to the product, e.g., NDA holder, manufacturer
etc.

An federal 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 control number. Public reporting burden
for this collection of information is estimated to average 20\
minutes per response, including time for reviewing instructions,
searching existing data sources, gathering and maintaining the\
necessary data, and completing and reviewing the collection of
information. Send comments regarding the burden estimate or any\
other aspect of this collection of information to:

###### The address for the U.S. mail delivery is: The address for special delivery is:

> The Food and Drug Administration **(UPS, FEDEX & Airborne Express)**
>
> HFD-330 The Food and Drug Administration
>
> 5600 Fishers Lane HFD-330
>
> Rockville, Md. 20852 11919 Rockville Pike (Montrose Metro 2)
>
> Rockville, Md. 20852