Sun Pharmaceutical Industries Inc.

FDA Drug Class II Terminated

Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b) 500-count bottles (NDC 62756-185-13), c)1000-count bottles (NDC 62756-185-18), Rx Only, Distributed by: Sun Pharma

December 1, 2022 Sun Pharmaceutical Industries Inc. Lot HAC1474A: 4296 Bottles, Lot HAC1474B: 145 Bottles, Lot HAC1503A: 2124 Bottles units

FDA Drug Class II Terminated

Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industr

October 18, 2022 Sun Pharmaceutical Industries Inc. N/A units

FDA Drug Class II Terminated

Pantoprazole Sodium for Delayed-Release Oral Suspension*40 mg* suspension in apple juice or applesauce only Each packet contains 40 mg pantoprazole equivalent to 45.1 mg of pantoprazole sodium USP (se

July 25, 2022 Sun Pharmaceutical Industries Inc. 14, 064 (30 sachets in a carton) units

FDA Drug Class II Terminated

Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd

June 27, 2022 Sun Pharmaceutical Industries Inc. 9552 bottles units

FDA Drug Class III Terminated

Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industri

June 21, 2022 Sun Pharmaceutical Industries Inc. 8640 bottles units

FDA Drug Class II Terminated

Testosterone Cypionate Injection, USP, 200mg/mL, CIII, Rx only, 1mL Single-dose vial, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuticals In

June 21, 2022 Sun Pharmaceutical Industries Inc. 50860 vials units

FDA Drug Class III Terminated

Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industrie

June 21, 2022 Sun Pharmaceutical Industries Inc. 5712 bottles units

FDA Drug Class II Terminated

Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutica

June 10, 2022 Sun Pharmaceutical Industries Inc. 47,500 vials units

FDA Drug Class II Terminated

Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutica

June 3, 2022 Sun Pharmaceutical Industries Inc. 97,450 vials units

FDA Drug Class II Terminated

Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose vial, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuticals Industries

June 3, 2022 Sun Pharmaceutical Industries Inc. 27 vials units

FDA Drug Class II Terminated

Clonazepam Orally Disintegrating Tablets, USP, 0.125mg, Rx Only, 60 Tablets, Mfd. by: Sun Pharmaceutical Industries Ltd. Mumbai, India, Dist. by: Sun Pharmaceutical Industries In., Cranbury, NJ 08512,

June 3, 2022 Sun Pharmaceutical Industries Inc. 4608 bottles units

FDA Drug Class II Terminated

medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured by Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, In

May 6, 2022 Sun Pharmaceutical Industries Inc. 4625 syringes units

FDA Drug Class II Terminated

medroxyPROGESTERone Acetate Injectable Suspension, USP, 25 x 1 mL Single-Dose Vial, 150 mg/mL, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pha

May 6, 2022 Sun Pharmaceutical Industries Inc. 26892 vials units

FDA Drug Class II Terminated

medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industri

May 6, 2022 Sun Pharmaceutical Industries Inc. 57997 syringes units

FDA Drug Class II Terminated

medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Single-Dose Vial, 150 mg/mL, Rx only, Manufactured for: Northstart Rx LLC, Memphis, TN, 38141, Manufactured by: Sun Pharmaceutical Industr

May 6, 2022 Sun Pharmaceutical Industries Inc. 180813 syringes units

FDA Drug Class II Terminated

medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat,

May 6, 2022 Sun Pharmaceutical Industries Inc. 79339 syringes units

FDA Drug Class III Terminated

buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count bottle, Rx only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical

April 29, 2022 Sun Pharmaceutical Industries Inc. 744 bottles units

FDA Drug Class III Terminated

buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg packaged in a) 60-count bottle (47335-737-86), b)100-count bottle (47335-737-88), c)500-count bottle (47335-737-13), Rx only Distribut

April 29, 2022 Sun Pharmaceutical Industries Inc. 9804 bottles units

FDA Drug Class III Terminated

Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 single-use vials (0.25 mL each) per box, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, ZI de la Guerie, F-5

April 1, 2022 Sun Pharmaceutical Industries Inc. 73,030 boxes units

FDA Drug Class II Terminated

Chlorthalidone Tablets USP 25 mg, Rx Only, 100 Tablets, Sun Pharma, Mfg. by: Fontida Bio Pharm Inc., 1100 Orthodox St. Philadephia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury,

February 7, 2022 Sun Pharmaceutical Industries Inc. 59,232 bottles units

FDA Drug Class II Terminated

Tadalafil Tablets, USP 5 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-075-01

October 25, 2021 Sun Pharmaceutical Industries Inc. 73,957 30-count bottles units

FDA Drug Class II Terminated

Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-077-01

October 25, 2021 Sun Pharmaceutical Industries Inc. 36,786 30-count bottles units

FDA Drug Class II Terminated

Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15 D

October 22, 2021 Sun Pharmaceutical Industries Inc. 696 Bottles units

FDA Drug Class III Terminated

AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10/240mg), 15-count blister packs, Manufactured by: Ohm Laboratories Inc., 1385 Livingston Avenue, North Brun

October 12, 2021 Sun Pharmaceutical Industries Inc. 46,584 blister packs units

FDA Drug Class III Terminated

Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg) , 10-count blister packs, Distributed By Major Pharmaceuticals, 17177 N Laurel

October 12, 2021 Sun Pharmaceutical Industries Inc. 22,752 blister packs units

FDA Drug Class II Terminated

Venlafaxine Tablets, USP 50 mg*, 100 Tablets Manufactured for Northstar Rx LLC Memphis, TN 38141 Manufactured by: ALKALOIDA Chemical Company Zrt. 4440 Tiszavasvari, Kabay Janos u.29.Hungary. Product

July 29, 2021 Sun Pharmaceutical Industries Inc. 2856 bottles units

FDA Drug Class III Terminated

Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances

May 7, 2021 Sun Pharmaceutical Industries Inc. N/A units

FDA Drug Class II Terminated

Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical

May 4, 2021 Sun Pharmaceutical Industries Inc. 50868 bottles units

FDA Drug Class II Terminated

Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor, 16 fl. oz., 473 mL bottles Rx Only, Manufactured by: Mikart, LLC, Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Indust

March 31, 2021 Sun Pharmaceutical Industries Inc. 13,834 bottles units

FDA Drug Class III Terminated

Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical In

March 25, 2021 Sun Pharmaceutical Industries Inc. 2520 bottles units

FDA Drug Class II Terminated

Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringe, Rx only, Distributor: Ferring Pharmaceuticals, Inc., Parsippany, NJ 07054 USA, Manufactured by: Sun Pharmaceutical Industries Lt

March 15, 2021 Sun Pharmaceutical Industries Inc. 91,211 syringes units

FDA Drug Class III Terminated

Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances

February 22, 2021 Sun Pharmaceutical Industries Inc. 37,400 cartons/60 vials per carton units

FDA Drug Class III Terminated

Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baro

February 5, 2021 Sun Pharmaceutical Industries Inc. 20,475 vials units

FDA Drug Class III Terminated

Testosterone Cypionate Injection, USP CIII 200mg/ml FOR INTRAMUSCULAR USE ONLY 1mL Single-dose vial Distributed by: Sun Pharma Ind. Inc, NJ 08512 Manufactured by: Sun Pharma Ind. Ltd., India NDC 62756

January 11, 2021 Sun Pharmaceutical Industries Inc. 36,275 cartons units

FDA Drug Class II Terminated

RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL 16 oz. For Oral Use Only Rx Only Manufactured by: Sun Pharmaceuticals Industries Limited Mohali, India Distrib

September 23, 2020 Sun Pharmaceutical Industries Inc. 747 bottles units

FDA Drug Class III Terminated

Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only, Mfg by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-783-86

July 6, 2020 Sun Pharmaceutical Industries Inc. 3516 bottles units

FDA Drug Class II Terminated

Doxycycline Capsules, USP, 75 mg, 100-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; ND

March 13, 2020 Sun Pharmaceutical Industries Inc. 624 bottles units

FDA Drug Class II Terminated

Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; ND

March 13, 2020 Sun Pharmaceutical Industries Inc. 172,320 bottles units

FDA Drug Class II Terminated

Atorvastatin Calcium Tablets, USP 40 mg, Rx only, 500-count bottle, Manufactured by: Sun Pharmaceutical Industries Limited Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury,

March 9, 2020 Sun Pharmaceutical Industries Inc. 1416 bottles units

FDA Drug Class II Terminated

Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL (100 mg/mL), 10 mL Multiple Dose Vial (NDC 62756-017-40), Rx only, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ, Manufactured by: S

January 14, 2020 Sun Pharmaceutical Industries Inc.

FDA Drug Class II Terminated

Testosterone Cypionate for Injection, 2,000 mg/10 mL (200 mg/mL), a) 1 mL Single Use vial (NDC 62756-015-40) and b) 10 mL Multiple Dose Vial (NDC 62756-016-40), Rx only, Distributed by: Sun Pharmaceut

January 14, 2020 Sun Pharmaceutical Industries Inc.

FDA Drug Class II Terminated

Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card, (62756-0522-69), Rx only, Sun Pharma, Cranbury, NJ

December 26, 2019 Sun Pharmaceutical Industries Inc. 207,585 blisters units

FDA Drug Class II Terminated

Sumatriptan Succinate Tablets, 50 mg, packaged in a) 9 (1x9) Unit-of use blister card (NDC 62756-521-69) and b) 100 count bottles, (NDC 62756-521-88), Rx only, Sun Pharma, Cranbury, NJ

December 26, 2019 Sun Pharmaceutical Industries Inc. 384/100 count bottles units

FDA Drug Class II Terminated

Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg/ Extended-Release Tablets, USP, Allergy & Congestion, 30-count box. Distributed by: Walgreen Co. 200 Wilmore Rd. Deerfield, IL 40015. Made

June 5, 2019 Sun Pharmaceutical Industries Inc. 14,399 30-count units units

FDA Drug Class II Terminated

Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended-Release Tablets, USP, Allergy & Congestion, 20-count box.Distributed by: Walgreen Co. 200 Wilmore Rd. Deerfield, IL 40015. Made i

June 5, 2019 Sun Pharmaceutical Industries Inc. 17,904 20-count units units

FDA Drug Class II Terminated

Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 30-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895. Made in India

June 5, 2019 Sun Pharmaceutical Industries Inc. 9528 30 count units units

FDA Drug Class II Terminated

Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 20-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895. Made in Ind

June 5, 2019 Sun Pharmaceutical Industries Inc. 17,136 20-count units units

FDA Drug Class II Terminated

BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distributed by : Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 49708-754-41

January 24, 2019 Sun Pharmaceutical Industries Inc. 69840 bottles units

FDA Drug Class I Terminated

Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL Lyophilized, 10 x 10 mg vials, Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway Halol-389

January 3, 2019 Sun Pharmaceutical Industries Inc. 12,534 cartons, 125,340 vials units

FDA Drug Class I Terminated

Vecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL Lyophilized, 10 x 20 mg vials, Rx Only, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway Halol-389 3

January 3, 2019 Sun Pharmaceutical Industries Inc. 1,384 cartons, 13,840 vials units