Consumer/user Metformin HCl Extended Release Tablets USP ... - California

The Board of Pharmacy has received notice of the following product recall. The Board strongly encourages pharmacies to immediately review their quality assurance and recall policies and procedures to determine if any corrective action is required.

Lupin Pharmaceuticals Inc. is initiating a recall of all lots of Metformin Hydrochloride ExtendedRelease Tablets USP, 500mg and 1000mg, to the consumer/user level. Additional analysis revealed that certain tested batches were above the Acceptable Daily Intake Limit for the impurity N-Nitrosodimethylamine (NDMA). Out of an abundance of caution, all lots within expiry are being recalled. The recalled lots are included in the tables below:

Metformin HCl Extended Release Tablets USP, 500mg; NDC: 68180-338-01 (100's)

Lot Number G808201 G808202 G808200 G900935 G901311 G900957 G900958

Exp. Date Aug-20 Aug-20 Aug-20 Dec-20 Dec-20 Dec-20 Dec-20

Lot Number G901006 G904803 G904804 G906551 G906552 G907375 G908605

Exp. Date Dec-20 May-21 May-21 Jul-21 Jul-21 Aug-21 Oct-21

Lot Number G908604 G002108 G002109 G002559

Exp. Date Oct-21 Jan-22 Jan-22 Feb-22

G002560

Feb-22

Metformin HCl Extended Release Tablets USP, 1000mg; NDC: 68180-339-09 (90's)

Lot Number G807093 G807147 G807208 G807479 G807480 G807830 G807092 G809471 G808155 G808074 G808115

Exp. Date Jul-20 Jul-20 Jul-20 Jul-20 Jul-20 Jul-20 Jul-20 Jul-20 Aug-20 Aug-20 Aug-20

Lot Number G900231 G900232 G903277 G903278 G903279 G903280 G903281 G903818 G904048 G904164 G906548

Exp. Date Nov-20 Nov-20 Mar-21 Mar-21 Mar-21 Mar-21 Mar-21 Apr-21 Apr-21 Apr-21 Jul-21

Lot Number G907239 G907255 G907256 G907263 G001802 G001804 G001803 G001805 G001806 G001807 G001808

Exp. Date Aug-21 Aug-21 Aug-21 Aug-21 Jan-22 Jan-22 Jan-22 Jan-22 Jan-22 Jan-22 Jan-22

Metformin HCl Extended Release Tablets USP, 1000mg; NDC: 68180-339-09 (90's) (continued)

Lot Number G808154 G900227 G900228 G900229 G900230

Exp. Date Aug-20 Nov-20 Nov-20 Nov-20 Nov-20

Lot Number G906549 G906550 G906547 G907279 G907364

Exp. Date Jul-21 Jul-21 Jul-21 Aug-21 Aug-21

Lot Number G001809 G001801 G002563

Exp. Date Jan-22 Jan-22 Feb-22

G002564

Feb-22

Metformin HCl Extended Release Tablets USP, 500mg; NDC: 68180-336-07 (60's)

Lot Number G808293 G808284 G808285 G808343

Exp. Date Aug-20 Aug-20 Aug-20 Aug-20

Lot Number G901201 G901202 G906915 G906913

Exp. Date Dec-20 Dec-20 Jul-21 Jul-21

Lot Number G906914 G002135

Exp. Date Jul-21 Jan-22

G002849

Feb-22

Metformin HCl Extended Release Tablets USP, 1000mg; NDC: 68180-337-07 (60's)

Lot Number G807619 G807620 G807733 G807734 G807735 G807445 G807617 G807618 G808042 G808043 G807349 G807350

Exp. Date Jul-20 Jul-20 Jul-20 Jul-20 Jul-20 Jul-20 Jul-20 Jul-20 Jul-20 Jul-20 Jul-20 Jul-20

Lot Number G900061 G900062 G900106 G900140 G900141 G900152 G809596 G809598 G810182 G810183 G810184 G810185

Exp. Date Oct-20 Oct-20 Oct-20 Oct-20 Oct-20 Oct-20 Oct-20 Oct-20 Oct-20 Oct-20 Oct-20 Oct-20

Lot Number G901002 G901003 G903182 G903183 G903236 G903237 G903238 G903155 G903156 G903157 G903158 G903159

Exp. Date Dec-20 Dec-20 Mar-21 Mar-21 Mar-21 Mar-21 Mar-21 Mar-21 Mar-21 Mar-21 Mar-21 Mar-21

Lot Number G807444 G807507 G807508 G807314 G807316 G807325 G807348 G807616 G807312 G807313 G807315 G808374 G808427 G808373 G808426 G900057 G900058 G900059 G900060

Exp. Date Jul-20 Jul-20 Jul-20 Jul-20 Jul-20 Jul-20 Jul-20 Jul-20 Jul-20 Jul-20 Jul-20 Aug-20 Aug-20 Aug-20 Aug-20 Oct-20 Oct-20 Oct-20 Oct-20

Lot Number G810186 G810187 G810188 G810189 G809554 G809556 G809557 G809558 G809559 G809548 G809549 G809550 G809551 G809552 G809553 G809555 G901004 G901005 G901053

Exp. Date Oct-20 Oct-20 Oct-20 Oct-20 Oct-20 Oct-20 Oct-20 Oct-20 Oct-20 Oct-20 Oct-20 Oct-20 Oct-20 Oct-20 Oct-20 Oct-20 Dec-20 Dec-20 Dec-20

Lot Number G903178 G903179 G903180 G903181 G903239 G001837 G001860 G001861 G001905 G001933 G001934 G001763 G001764 G001765 G001766 G001767 G001795

Exp. Date Mar-21 Mar-21 Mar-21 Mar-21 Mar-21 Jan-22 Jan-22 Jan-22 Jan-22 Jan-22 Jan-22 Jan-22 Jan-22 Jan-22 Jan-22 Jan-22 Jan-22

G001836

Jan-22

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