URGENT DRUG RECALL- RETAIL LEVEL 05/03/2019

PRODUCT RECALL RESPONSE FORM

URGENT DRUG RECALL- RETAIL LEVEL 05/03/2019

Please complete the required information and fax to or email to

1-817-868-5362 rxrecalls@

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

Product Detail

PRAMIPEXOLE DI HCL Tablets 0.125MG, 1000'S BULK PRAMIPEXOLE DI HCL Tablets 0.125MG, 1000'S BULK PRAMIPEXOLE DI HCL Tablets 0.125MG, 1000'S BULK PRAMIPEXOLE DI HCL Tablets 0.125MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.125MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.125MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.125MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.125MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.125MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.125MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.125MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.125MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.125MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.125MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.125MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.125MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.125MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.125MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.125MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.125MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.125MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.125MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.125MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.125MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.125MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.125MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.125MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.25MG, 1000'S BULK PRAMIPEXOLE DI HCL Tablets 0.25MG, 1000'S BULK PRAMIPEXOLE DI HCL Tablets 0.25MG, 1000'S BULK PRAMIPEXOLE DI HCL Tablets 0.25MG, 1000'S BULK PRAMIPEXOLE DI HCL Tablets 0.25MG, 1000'S BULK PRAMIPEXOLE DI HCL Tablets 0.25MG, 1000'S BULK PRAMIPEXOLE DI HCL Tablets 0.25MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.25MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.25MG, 90'S Bottle

NDC

Exp Lot No.

Date

68382-196-10 68382-196-10 68382-196-10 68382-196-16 68382-196-16 68382-196-16 68382-196-16 68382-196-16 68382-196-16 68382-196-16 68382-196-16 68382-196-16 68382-196-16 68382-196-16 68382-196-16 68382-196-16 68382-196-16 68382-196-16 68382-196-16 68382-196-16 68382-196-16 68382-196-16 68382-196-16 68382-196-16 68382-196-16 68382-196-16 68382-196-16 68382-197-10 68382-197-10 68382-197-10 68382-197-10 68382-197-10 68382-197-10 68382-197-16 68382-197-16 68382-197-16

M714919 M815081 M900475 M714176 M714177 M714917 M714918 M715594 M715595 M802190 M802191 M808673 M811125 M811126 M811127 M811128 M811129 M815082 M815083 M815084 M815085 M815086 M900476 M900477 M900478 M900479 M900481 M706803 M713438 M801704 M808306 M812484 M820264 M706802 M706804 M706907

Dec-19 Aug-20 Dec-20 Oct-19 Oct-19 Nov-19 Dec-19 Dec-19 Dec-19 Jan-20 Feb-20 May-20 Jun-20 Jun-20 Jun-20 Jun-20 Jun-20 Aug-20 Aug-20 Aug-20 Aug-20 Aug-20 Dec-20 Dec-20 Dec-20 Dec-20 Dec-20 May-19 Sep-19 Dec-19 May-20 Jul-20 Nov-20 May-19 May-19 May-19

No. of Bottle Purchased

No of Bottles consumed

No. of bottles in Possession

No of Bottles to be

returned

Page 1 of 4

Recall- Pramipexole Dihydrochloride Tablets ? May 2019

PRAMIPEXOLE DI HCL Tablets 0.25MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.25MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.25MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.25MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.25MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.25MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.25MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.25MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.25MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.25MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.25MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.25MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.25MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.25MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.25MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.25MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.25MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.25MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.25MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.25MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.25MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.25MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.25MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.25MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.25MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.25MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.25MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.25MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.25MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.25MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.25MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.25MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.25MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.5MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.5MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.5MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.5MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.5MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.5MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.5MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.5MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.5MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.5MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.5MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.5MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.5MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.5MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.5MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.5MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.5MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.5MG, 90'S Bottle

68382-197-16 68382-197-16 68382-197-16 68382-197-16 68382-197-16 68382-197-16 68382-197-16 68382-197-16 68382-197-16 68382-197-16 68382-197-16 68382-197-16 68382-197-16 68382-197-16 68382-197-16 68382-197-16 68382-197-16 68382-197-16 68382-197-16 68382-197-16 68382-197-16 68382-197-16 68382-197-16 68382-197-16 68382-197-16 68382-197-16 68382-197-16 68382-197-16 68382-197-16 68382-197-16 68382-197-16 68382-197-16 68382-197-16 68382-198-16 68382-198-16 68382-198-16 68382-198-16 68382-198-16 68382-198-16 68382-198-16 68382-198-16 68382-198-16 68382-198-16 68382-198-16 68382-198-16 68382-198-16 68382-198-16 68382-198-16 68382-198-16 68382-198-16 68382-198-16

M706909 M707028 M714180 M714181 M714923 M714924 M717063 M717064 M801705 M801706 M801707 M801708 M808307 M808308 M808309 M808310 M812479 M812481 M812482 M812483 M815787 M815788 M815789 M815790 M815791 M820265 M820266 M820267 M820268 M820269 M903040 M903041 M903042 M713431 M713432 M714172 M714173 M800552 M800553 M800554 M800555 M800556 M811135 M812818 M812819 M812820 M812821 M815777 M815778 M815779 M815780

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

Page 2 of 4

Recall- Pramipexole Dihydrochloride Tablets ? May 2019

PRAMIPEXOLE DI HCL Tablets 0.5MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.5MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.5MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.5MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.5MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 0.5MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 1MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 1MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 1MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 1MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 1MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 1MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 1MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 1MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 1MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 1MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 1MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 1MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 1MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 1MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 1MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 1MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 1MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 1MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 1MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 1MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 1MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 1MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 1MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 1MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 1MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 1MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 1MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 1MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 1.5MG, 1000'S BULK PRAMIPEXOLE DI HCL Tablets 1.5MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 1.5MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 1.5MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 1.5MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 1.5MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 1.5MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 1.5MG, 90'S Bottle PRAMIPEXOLE DI HCL Tablets 1.5MG, 90'S Bottle

68382-198-16 68382-198-16 68382-198-16 68382-198-16 68382-198-16 68382-198-16 68382-199-16 68382-199-16 68382-199-16 68382-199-16 68382-199-16 68382-199-16 68382-199-16 68382-199-16 68382-199-16 68382-199-16 68382-199-16 68382-199-16 68382-199-16 68382-199-16 68382-199-16 68382-199-16 68382-199-16 68382-199-16 68382-199-16 68382-199-16 68382-199-16 68382-199-16 68382-199-16 68382-199-16 68382-199-16 68382-199-16 68382-199-16 68382-199-16 68382-200-10 68382-200-16 68382-200-16 68382-200-16 68382-200-16 68382-200-16 68382-200-16 68382-200-16 68382-200-16

M815781 M901927 M901929 M901931 M901933 M902089 M714186 M714187 M714188 M714903 M714904 M714905 M818140 M715586 M715587 M801441 M801442 M801443 M801444 M801445 M811152 M811153 M811154 M811155 M811156 M814298 M814299 M814300 M814301 M814302 M818136 M818137 M818138 M818139 M714190 M713435 M713436 M714191 M808184 M808185 M808186 M817634 M817635

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

Page 3 of 4

Recall- Pramipexole Dihydrochloride Tablets ? May 2019

__ 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

___ 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 4 of 4

Recall- Pramipexole Dihydrochloride Tablets ? May 2019

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