PRODUCT RECALL RESPONSE FORM URGENT DRUG RECALL- …

PRODUCT RECALL RESPONSE FORM

URGENT DRUG RECALL- RETAIL LEVEL 05/03/2019

Please complete the required information and fax to 1-817-868-5362 or email to rxrecalls@

To the Attention of Drug Safety/ Recall Services-Zydus Pharmaceuticals USA Inc.

Product Detail

Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle

NDC

68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06

Lot No.

M706674 M706676 M707685 M711219 M711220 M711221 M711222 M711269 M801027 M801028 M801029 M801030 M802206 M805195 M805196 M805197 M805199 M805202 M805944 M805945 M805948 M805951 M805953 M805956 M805957 M805958 M805959 M812457 M812458 M812459 M813912 M813913 M813914 M813915 M813916 M815768

Exp Date

May-19 May-19 May-19 Aug-19 Aug-19 Aug-19 Aug-19 Aug-19 Dec-19 Dec-19 Dec-19 Dec-19 Jan-20 Feb-20 Feb-20 Feb-20 Mar-20 Mar-20 Mar-20 Mar-20 Mar-20 Mar-20 Mar-20 Mar-20 Mar-20 Mar-20 Mar-20 Jun-20 Jul-20 Jul-20 Jul-20 Jul-20 Jul-20 Jul-20 Jul-20 Sep-20

No. of Bottle Purchased

No of Bottles consumed

No. of bottles in Possession

No of Bottles to be returned

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Recall- Anastrozole Tablets, USP, 1mg ? May 2019

Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 30's Bottle Anastrozole Tablets, USP, 1mg, 1000's Bottle Anastrozole Tablets, USP, 1mg, 1000's Bottle Anastrozole Tablets, USP, 1mg, 1000's Bottle Anastrozole Tablets, USP, 1mg, 1000's Bottle

68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-06 68382-209-10 68382-209-10 68382-209-10 68382-209-10

M815769 M818119 M818120 M818121 M818274 M818635 M819270 M819861 M819862 M900921 M900922 M900923 M900924 M900925 M902634 M902635 M708570 M711270 M802207 M812460

Sep-20 Oct-20 Oct-20

Oct-20 Sep-20 Oct-20 Nov-20 Nov-20 Nov-20 Dec-20 Dec-20 Dec-20 Dec-20 Dec-20 Jan-21 Jan-21 May-19 Aug-19 Jan-20 Jul-20

No. of Returns kit required: _________________________ Please mark as applicable

__ We currently do not have any inventory of the above listed Lot/bottles __ We are notifying our customers __ We have identified and notified my customers that were shipped or may have been shipped this product by________________________________; __ Attached is the list of customers who received/ may have received this product. Please

notify my customers. Any adverse event associated with recalled product? ___ Yes ___ No If yes, please explain:

Please check appropriate box to describe your business ___ Wholesaler/Distributor ___ Retailers ___ Repackager ___ Manufacturer ___ Pharmacy- Retail ___ Hospital/ Medical Facility

Page 2 of 3

Recall- Anastrozole Tablets, USP, 1mg ? May 2019

___ Hospital Pharmacies

___ Medical Laboratory

___ Other: _________________________________________________________________

Name: ______________________________

Title: ______________________________

Tel Number: ___________________________

Firm Name: ___________________________

DEA#_______________

Address: ______________________________

City/ State: _____________________________

If you have not purchased, the concerned lot directly from Zydus Pharmaceuticals USA Inc., then please provide details

of your wholesaler: _______________________________(Name, City) DEA#_______________

Signature: ______________________________

Date: _________________

Page 3 of 3

Recall- Anastrozole Tablets, USP, 1mg ? May 2019

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