Wockhardt Usa Inc.

FDA Drug Class III Terminated

Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured by: Wockhardt Limited H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India, Distributed by: Wockhardt, USA LLC, 2

August 22, 2017 Wockhardt Usa Inc. 5050 bottles units

FDA Drug Class II Terminated

Lisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 64

July 29, 2015 Wockhardt Usa Inc. 3378 bottles units

FDA Drug Class II Terminated

Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 646

July 29, 2015 Wockhardt Usa Inc. 1704 bottles units

FDA Drug Class II Terminated

Metoprolol Succinate Extended-Release Tablets, USP, 100 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0736-02), B) 500 Count Bottles (NDC: 64679-0736-03), and C) 12 x 30 Tablet Dispenser Pa

April 22, 2015 Wockhardt Usa Inc. A) 77,967 Bottles, B) 26,785 Bottles, and C) 5,463 Cartons. units

FDA Drug Class II Terminated

Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blv

April 22, 2015 Wockhardt Usa Inc. 16,276 Bottles units

FDA Drug Class II Terminated

Zonisamide Capsules, 25 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 070

April 22, 2015 Wockhardt Usa Inc. 68,066 Bottles units

FDA Drug Class II Terminated

Amlodipine Besylate Tablets, 5 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-422-01) and B) 1000 Count Bottles (NDC: 64679-422-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, Indi

April 22, 2015 Wockhardt Usa Inc. A) 146,959 Bottles, B) 73,445 Bottles. units

FDA Drug Class II Terminated

Captopril Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0904-01) and B) 1000 Count Bottles (NDC: 64679-0904-02), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India.

April 22, 2015 Wockhardt Usa Inc. A) 216,329 Bottles and B) 18,514 Bottles. units

FDA Drug Class II Terminated

Zonisamide Capsules, 100 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07

April 22, 2015 Wockhardt Usa Inc. 491,360 Bottles units

FDA Drug Class II Terminated

Lisinopril Tablets USP, 30 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-953-01) and B) 500 Count Bottles (NDC: 64679-953-05), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India.

April 22, 2015 Wockhardt Usa Inc. A) 63,203 Bottles and B) 6,094 Bottles. units

FDA Drug Class II Terminated

Famotodine Tablets, USP, 10 mg Tablets, For Repacking Only, Packaged in 50,000 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 W

April 22, 2015 Wockhardt Usa Inc. 1,002 Drums units

FDA Drug Class II Terminated

Lisinopril Tablets USP, 10 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-929-01), B) 500 Count Bottles (NDC: 64679-929-05), and C) 1000 Count Bottles (NDC: 64679-929-06), Rx Only. Manufactu

April 22, 2015 Wockhardt Usa Inc. A) 133,920 Bottles, B) 6705 Bottles, and C) 137,659 Bottles. units

FDA Drug Class II Terminated

Famotodine Tablets, USP, 20 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-936-01), B) 100 Count Bottles(NDC: 64679-936-02), and C) 1000 Count Bottles (NDC: 64679-936-03), Rx only. Manufact

April 22, 2015 Wockhardt Usa Inc. A) 69,008 Bottles, B) 399,730 Bottles, and C) 58,116 Bottles. units

FDA Drug Class II Terminated

Famotodine Tablets, USP, 20 mg Tablets, For Repacking Only, Packaged in 6500 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Wat

April 22, 2015 Wockhardt Usa Inc. 539 Drums units

FDA Drug Class II Terminated

Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA

April 22, 2015 Wockhardt Usa Inc. 59,729 Bottles units

FDA Drug Class II Terminated

Famotodine Tablets, USP, 40 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-937-01), B) 100 Count Bottles (NDC: 64679-937-02), and C) 1000 Count Bottles (NDC: 64679-937-03), Rx only. Manufac

April 22, 2015 Wockhardt Usa Inc. A) 70,428 Bottles, B) 128,420 Bottles, and C) 8,101 Bottles. units

FDA Drug Class II Terminated

Metoprolol Succinate Extended-Release Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0735-02), B) 500 Count Bottles (NDC: 64679-0735-03), C) 4000 Count Pouches, For Repackin

April 22, 2015 Wockhardt Usa Inc. A) 136,839 Bottles, B) 37,184 Bottles, C) 309 Pouches, and D) 9,764 Cartons. units

FDA Drug Class II Terminated

Zolpidem Tartrate Tablets, 10 mg Tablets, CIV, Packaged in A) 100 Count Bottles (NDC: 64679-715-01) and B) 500 Count Bottles (NDC: 64679-715-04), Rx only. Manufactured by: Wockhardt Limited, Mumbai,

April 22, 2015 Wockhardt Usa Inc. A) 36,213 Bottles and B) 12,824 Bottles. units

FDA Drug Class II Terminated

Lisinopril Tablets USP, 40 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-942-01), B) 500 Count Bottles (NDC: 64679-942-05), and C) 1000 Count Bottles (NDC: 64679-942-02), Rx Only. Manufactu

April 22, 2015 Wockhardt Usa Inc. A) 174,571 Bottles, B) 66,960 Bottles, and C) 48,988 Bottles. units

FDA Drug Class II Terminated

Amlodipine Besylate Tablets, 10 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-423-01) and B) 1000 Count Bottles (NDC: 64679-423-02, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, In

April 22, 2015 Wockhardt Usa Inc. A) 152,164 Bottles and B) 50,991 Bottles. units

FDA Drug Class II Terminated

Lisinopril Tablets USP, 20 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-941-01), B) 500 Count Bottles (NDC: 64679-941-05), and C) 1000 Count Bottles (NDC: 64679-941-06), Rx Only. Manufact

April 22, 2015 Wockhardt Usa Inc. A) 121,608 Bottles, B) 11,000 Bottles, and C) 152,773 Bottles. units

FDA Drug Class II Terminated

Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany,

April 22, 2015 Wockhardt Usa Inc. 124,034 Bottles units

FDA Drug Class II Terminated

Azithromycin Tablets, USP, 500 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0964-01) and B) 3 x 3 Tablet Card Cartons (NDC: 64679-964-05), Rx only. Manufactured by: Wockhardt Limited, Mumba

April 22, 2015 Wockhardt Usa Inc. A) 112,120 Bottles and B) 178,580 Cartons. units

FDA Drug Class II Terminated

Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules, Packaged as A) 100 Count Bottles (NDC: 64679-720-01) and B) 1000 Count Bottles (NDC: 64679-720-02), Rx Only. Manufactured by: Wockhardt Limite

April 22, 2015 Wockhardt Usa Inc. 53,894 Bottles units

FDA Drug Class II Terminated

Tamsulosin Hydrochloride Capsules, USP*, 0.4 mg Capsules, Packaged in A) 100 Count Bottles (NDC: 64679-516-02) and B) 500 Count Bottles (NDC: 64679-516-03), Rx Only. Manufactured by: Wockhardt Limited

April 22, 2015 Wockhardt Usa Inc. 407,958 Bottles units

FDA Drug Class II Terminated

Lamotrigine Extended-Release Tablets, 25 mg Tablets, 30 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 0

April 22, 2015 Wockhardt Usa Inc. 5,910 Bottles units

FDA Drug Class II Terminated

Azithromycin Tablets, USP, 250 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0961-01), B) 3,500 Count Pouches (NDC: 64679-961-08), and C) 3 x 6 Tablet Card Cartons (NDC: 64679-961-05), Rx on

April 22, 2015 Wockhardt Usa Inc. A) 280,520 Bottles, B) 571 Pouches, and C) 1,629,253 Cartons. units

FDA Drug Class II Terminated

Lisinopril Tablets USP, 2.5 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-927-01) and B) 500 Count Bottles (NDC: 64679-927-05), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. D

April 22, 2015 Wockhardt Usa Inc. A) 149,924 Bottles and B) 35,012 Bottles units

FDA Drug Class II Terminated

Metoprolol Succinate Extended-Release Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0734-02), B) 500 Count Bottles (NDC: 64679-0734-03), C) 8000 Count Pouches, For Repackin

April 22, 2015 Wockhardt Usa Inc. A) 132,409 Bottles, B) 41,257 Bottles, C) 576 Pouches, and D) 6,429 Cartons. units

FDA Drug Class II Terminated

Metoprolol Succinate Extended-Release Tablets, USP, 200 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0737-02) and B) 500 Count Bottles (NDC: 64679-0737-03), Rx Only. Manufactured by: Wockh

April 22, 2015 Wockhardt Usa Inc. A) 33,422 Bottles and B) 940 Bottles. units

FDA Drug Class II Terminated

Captopril Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0903-01) and B) 1000 Count Bottles (NDC: 64679-0903-02), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India.

April 22, 2015 Wockhardt Usa Inc. A) 162,743 Bottles and B) 14,205 Bottles units

FDA Drug Class II Terminated

Zonisamide Capsules, 50 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 070

April 22, 2015 Wockhardt Usa Inc. 84,542 Bottles units

FDA Drug Class II Terminated

Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, For Repackaging Only, Packaged in 4500 Count Pouches, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: W

April 22, 2015 Wockhardt Usa Inc. 848 Pouches units

FDA Drug Class II Terminated

Azithromycin Tablets, USP, 600 mg Tablets, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ

April 22, 2015 Wockhardt Usa Inc. 7,584 Bottles units

FDA Drug Class II Terminated

Lisinopril Tablets USP, 5 mg Tablets,Packaged in A) 100 Count Bottles (NDC: 64679-928-01), B) 500 Count Bottles (NDC: 64679-928-05), and C) 1000 Count Bottles (NDC: 64679-928-06), Rx Only. Manufacture

April 22, 2015 Wockhardt Usa Inc. A) 128,594 Bottles, B) 25,472 Bottles, and C) 62,124 Bottles. units

FDA Drug Class II Terminated

Zolpidem Tartrate Tablets, 5 mg Tablets, CIV, Packaged in 100 Tablet Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippa

April 22, 2015 Wockhardt Usa Inc. 37,791 Bottles units

FDA Drug Class II Terminated

Captopril Tablets, USP, 100 mg Tablets, Packaged in 100 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 0

April 22, 2015 Wockhardt Usa Inc. 68,969 Bottles units

FDA Drug Class II Terminated

Lansoprazole Delayed-Release Capsules, USP, 30 mg Capsules, Packaged in A) 30 Count Bottles (NDC: 64679-0670-01), B) 90 Count Bottles (NDC: 64679-0670-07), and C) 1000 Count Bottles (NDC: 64679-0670-0

April 22, 2015 Wockhardt Usa Inc. A) 178,832 Bottles, B) 15,787 Bottles, and C) 459 Bottles. units

FDA Drug Class II Terminated

Captopril Tablets, USP 12.5 mg, Rx Only, a) 100 count bottles NDC 64679-902-01, b) 1000 count bottles NDC 64679-902-02, Manufactured by Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt USA

March 12, 2015 Wockhardt Usa Inc. 93,393 bottles units

FDA Drug Class II Terminated

Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle (NDC 64679-737-02), b) 500-count bottle (NDC 64679-737-03) Rx only, Manufactured by: Wockhardt Limited Mumbai,

July 24, 2014 Wockhardt Usa Inc. 11,661 HDPE bottles units

FDA Drug Class III Terminated

buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA, LLC, 20 Waterview Blvd, Parsippan

July 14, 2014 Wockhardt Usa Inc. 840 bottles units

FDA Drug Class III Terminated

Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64679-735-08), Manufactured by: Wockhardt Limited, Mumbai, India

April 17, 2014 Wockhardt Usa Inc. 1,118,400 extended release tablets units

FDA Drug Class II Terminated

Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Water view Blvd., Parsi

April 10, 2014 Wockhardt Usa Inc. 8712 Bottles units

FDA Drug Class II Terminated

Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippa

April 1, 2014 Wockhardt Usa Inc. 109,744 bottles units

FDA Drug Class II Terminated

Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, 1000 tablets bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd Parsippan

November 27, 2013 Wockhardt Usa Inc. 1129 bottles units