AVKARE Inc.

FDA Drug Class III Terminated

Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-367-10, UPC 3 42291 36710 4

July 20, 2022 AVKARE Inc. 8328 bottles units

FDA Drug Class III Terminated

Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-661-13

June 9, 2021 AVKARE Inc. 10 cartons units

FDA Drug Class II Terminated

Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01.

December 7, 2020 AVKARE Inc. 38715 bottles units

FDA Drug Class I Terminated

TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-834-10

December 7, 2020 AVKARE Inc. 14368 bottles units

FDA Drug Class II Terminated

Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 NDC 42291-564-12

October 30, 2020 AVKARE Inc. 15,678 bottles units

FDA Drug Class II Terminated

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC 42291-611-90) b) 180 count (NDC 42291-611-18) c) 500 count (NDC 42291-611-50) bottles, Rx Only Manufactured for: AvKARE, I

June 4, 2020 AVKARE Inc. 88,545 bottles units

FDA Drug Class II Terminated

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (NDC 50268-531-15); b) 90 count (NDC 42291-610-90); c) 180 count (NDC 42291-610-18); d) 360 count (NDC 42291-610-36); e) 1000

June 4, 2020 AVKARE Inc. 1,586,913 bottles units

FDA Drug Class III Terminated

Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 42291-368-50, Manufactured for: AvKARE, Inc. Pulaski, TN 38478.

May 28, 2020 AVKARE Inc. 4124 bottles units

FDA Drug Class II Terminated

Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-282-13.

January 7, 2020 AVKARE Inc. 3,989 cartons units

FDA Drug Class II Terminated

AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 a) 1000 tablets NDC 42291-724-10; b) 18

November 14, 2019 AVKARE Inc. 631,138 bottles units

FDA Drug Class II Terminated

AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, Inc. Pulaski, TN 38478 a) 250 tablets NDC 42291-725-25; b) 30 tablets NDC 42291-725-30

November 14, 2019 AVKARE Inc. 104,797 bottles units

FDA Drug Class II Terminated

AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufactured for: AvKARE, Inc. Pulaski, TN 38478

October 17, 2019 AVKARE Inc. 7293 bottles units

FDA Drug Class II Terminated

AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pulaski, TN 38478

October 17, 2019 AVKARE Inc. 1351 bottles units

FDA Drug Class II Terminated

AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50.

August 28, 2019 AVKARE Inc. 5953 bottles units

FDA Drug Class II Ongoing

Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-516-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478

April 24, 2019 AVKARE Inc. 846 cartons (42,300 tablets) units

FDA Drug Class II Ongoing

Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-517-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478

April 24, 2019 AVKARE Inc. 1438 cartons (71,900 tablets) units

FDA Drug Class III Terminated

Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --- NDC 42291-795-30

April 3, 2019 AVKARE Inc. 397 bottles units

FDA Drug Class II Terminated

Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-513-15

March 5, 2019 AVKARE Inc. N/A units

FDA Drug Class II Terminated

Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-514-15

March 5, 2019 AVKARE Inc. N/A units

FDA Drug Class II Terminated

Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 ---- NDC 50268-517-15

March 5, 2019 AVKARE Inc. N/A units

FDA Drug Class III Terminated

Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 42291-634-01) and b) 500 tablets (NDC 42291-634-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478

March 1, 2019 AVKARE Inc. a) 2947 and b) 3379 units

FDA Drug Class II Terminated

Germ Bloc Health Hand Sanitizer Foam (benzalkonium chloride 0.13%) 7.5fl.oz./222mL refill bags, AvKARE, Inc. Pulaski, TN 38478 www.avkare.com, NDC 5026835427, UPC 3 50268 35408

November 20, 2018 AVKARE Inc. 1602 bags units

FDA Drug Class II Terminated

Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose Manufactured for: AvKARE, Inc. Pulaski, TN 38478

August 14, 2018 AVKARE Inc. 6776 cartons (338,800 tablets) units

FDA Drug Class II Terminated

Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478

August 14, 2018 AVKARE Inc. 728 cartons (36,400 tablets) units

FDA Drug Class II Terminated

Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-786-13 Manufactured for: AvKARE, Inc. Pulaski, TN 38478

August 14, 2018 AVKARE Inc. 1496 cartons (44,880 tablets) units

FDA Drug Class II Terminated

Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-785-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478

August 14, 2018 AVKARE Inc. 818 cartons (40,900 tablets) units

FDA Drug Class II Terminated

Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-069-15

March 30, 2018 AVKARE Inc. 2135 cartons units

FDA Drug Class II Terminated

Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 38478, NDC 50268-512-15.

January 3, 2018 AVKARE Inc. 237 cartons units

FDA Drug Class II Terminated

Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 5026828311), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-283-

October 6, 2017 AVKARE Inc. 274 cartons units

FDA Drug Class III Terminated

Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 50268-804-12

July 19, 2017 AVKARE Inc. 1172 cartons (23440 tablets) units

FDA Drug Class II Terminated

Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-307-13

February 15, 2017 AVKARE Inc. 116 cartons units

FDA Drug Class III Terminated

Quinapril Tablets USP, 5 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 5026868815, NDC 50268-688-15

February 27, 2015 AVKARE Inc. 214 unit dose packs units

FDA Drug Class III Terminated

Quinapril Tablets USP, 40 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 5026869115, NDC 50268-691-15

February 27, 2015 AVKARE Inc. 431 unit dose packs units