Zydus Pharmaceuticals USA Inc

FDA Drug Class II Terminated

Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington,

January 31, 2020 Zydus Pharmaceuticals USA Inc 2207 Vials units

FDA Drug Class II Terminated

Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC

May 6, 2019 Zydus Pharmaceuticals USA Inc 168,330 90-count bottles units

FDA Drug Class II Terminated

MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-917-11

May 6, 2019 Zydus Pharmaceuticals USA Inc 40872 25-count bottles units

FDA Drug Class II Terminated

Anastrozole Tablets, USP, 1 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534. NDC 68382

May 6, 2019 Zydus Pharmaceuticals USA Inc 768 1000-count bottles units

FDA Drug Class II Terminated

Pramipexole Dihydrochloride Tablets 1 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 683

May 6, 2019 Zydus Pharmaceuticals USA Inc 113,304 90-count bottles units

FDA Drug Class II Terminated

MethylPREDNISolone Tablets, USP 32 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-919-11

May 6, 2019 Zydus Pharmaceuticals USA Inc 13,564 25-count bottles units

FDA Drug Class II Terminated

Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. NDC 68382-197-10

May 6, 2019 Zydus Pharmaceuticals USA Inc 3,156 1000-count bottles units

FDA Drug Class II Terminated

MethylPREDNISolone Tablets, USP, 4 mg, 100 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India NDC 68382-916-01

May 6, 2019 Zydus Pharmaceuticals USA Inc 34521 100-count bottles units

FDA Drug Class II Terminated

Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534.

May 6, 2019 Zydus Pharmaceuticals USA Inc 204 1000-count bottles units

FDA Drug Class II Terminated

ANASTROZOLE Tablets, 1 mg, Rx Only, 30-count bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 NDC 68382-209-06

May 6, 2019 Zydus Pharmaceuticals USA Inc 1,425,264 30-count bottles units

FDA Drug Class II Terminated

Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle, Rx only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ NDC 68382-2

May 6, 2019 Zydus Pharmaceuticals USA Inc 47,664 90-count bottles units

FDA Drug Class II Terminated

Pramipexole DihydrochlorideTablets 0.125 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC

May 6, 2019 Zydus Pharmaceuticals USA Inc 143,184 90-count bottles units

FDA Drug Class II Terminated

MethylPREDNISolone Tablets, USP 4 mg per tablet, 21 Tablets dosepack, Rx Only, Made in India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-916-34

May 6, 2019 Zydus Pharmaceuticals USA Inc N/A units

FDA Drug Class II Terminated

Pramipexole Dihydrochoride Tablets 0.25 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 6

May 6, 2019 Zydus Pharmaceuticals USA Inc 215,760 90-count bottles units

FDA Drug Class II Terminated

MethylPREDNISolone Tablets, USP 16 mg, 50 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-918-18

May 6, 2019 Zydus Pharmaceuticals USA Inc N/A units

FDA Drug Class II Terminated

Carvedilol Tablets, USP, 6.25 mg, 500 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ USA 08534 NDC 68382-093-05

April 25, 2019 Zydus Pharmaceuticals USA Inc 3900 units

FDA Drug Class II Terminated

Acyclovir Tablets, USP, 400 mg, 100 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ USA 08534 NDC 68382-791-01

April 25, 2019 Zydus Pharmaceuticals USA Inc N/A units

FDA Drug Class III Terminated

Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; NDC 68382-092-05

April 22, 2019 Zydus Pharmaceuticals USA Inc 7668 bottles units

FDA Drug Class II Terminated

Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count (NDC 68382-099-05), and c) 1000 count (NDC 68382-099-10) count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, A

November 20, 2017 Zydus Pharmaceuticals USA Inc 19812 bottles units

FDA Drug Class II Terminated

Paroxetine tablets USP, 30mg, 30-count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534, NDC 68382-099-0

August 18, 2017 Zydus Pharmaceuticals USA Inc 44800 bottles units

FDA Drug Class II Terminated

Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle (NDC 68382-033-01) b.) 500-count bottle (NDC 68382-033-05), Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, Indi

May 10, 2017 Zydus Pharmaceuticals USA Inc 108,726 HDPE bottles units

FDA Drug Class II Terminated

Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054,

May 10, 2017 Zydus Pharmaceuticals USA Inc 108,096 HDPE bottles units

FDA Drug Class II Terminated

Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC 68382-032-01), b.) 500-count bottle (NDC 68382-032-05),Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Di

May 10, 2017 Zydus Pharmaceuticals USA Inc 115,122 HDPE bottles units

FDA Drug Class II Terminated

Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01) and b) 500 count (NDC 68382-033-05) bottles, Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India,

March 15, 2017 Zydus Pharmaceuticals USA Inc 32628 bottles units

FDA Drug Class II Terminated

ATENOLOL Tablets, USP, 50 mg, packaged in a) 100-count bottles (NDC 68382-023-01) and b) 1000-count bottles (NDC 68382-023-10), Rx only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by:

March 6, 2017 Zydus Pharmaceuticals USA Inc 9561 bottles units

FDA Drug Class III Terminated

BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 500 count bottles (NDC 68382-354-05), Manufactured by: Cadila Healthcare LTD. Ah

November 2, 2016 Zydus Pharmaceuticals USA Inc 16,356 bottles units

FDA Drug Class III Terminated

BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA inc.

August 3, 2016 Zydus Pharmaceuticals USA Inc 2,472 units units

FDA Drug Class II Terminated

Venlafaxine HCL ER Capsule USP, 75mg, packaged in a) 30-count bottles (NDC 68382-035-06), b) 90-count bottles (NDC 68382-035-16), and c) 1000-count bottles, (NDC 68382-035-10), Rx only, Manufactured b

July 19, 2016 Zydus Pharmaceuticals USA Inc N/A units

FDA Drug Class II Terminated

Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 68382-036-06), b) 90-count bottles (NDC 68382-036-16), and c) 1000-count bottles, (NDC 68382-036-10), Rx only, Manufactured

July 19, 2016 Zydus Pharmaceuticals USA Inc 223,776 bottles units

FDA Drug Class II Terminated

Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufactured by: Cadila Healthcare ltd., Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, ND

May 9, 2016 Zydus Pharmaceuticals USA Inc 14,808 bottles units

FDA Drug Class III Terminated

risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 0853

January 14, 2016 Zydus Pharmaceuticals USA Inc 9504 Bottles units

FDA Drug Class II Terminated

Benzonatate Capsules, USP, 100 mg, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA, In, Pennington, NJ USA 08534; 100-bottle capsules -

December 23, 2014 Zydus Pharmaceuticals USA Inc 19,536 units units

FDA Drug Class II Terminated

Benzonatate Capsules, USP, 200 mg, 100-count bottles, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA, In, Pennington, NJ USA 08534; NDC 6

November 26, 2014 Zydus Pharmaceuticals USA Inc 58,920 bottles units

FDA Drug Class III Terminated

Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534,

October 1, 2014 Zydus Pharmaceuticals USA Inc 15,144 bottles units

FDA Drug Class III Terminated

BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only. Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA, Inc. NDC: 68382-248-01

September 24, 2014 Zydus Pharmaceuticals USA Inc 63,648 Bottles units

FDA Drug Class II Terminated

TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ USA 08534. NDC 68382-141-14

September 15, 2014 Zydus Pharmaceuticals USA Inc 14,568 Bottles units

FDA Drug Class II Terminated

ZyGenerics ATENOLOL Tablets, USP 25 mg 1000 count bottle, Rx Only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08634 USA NDC

August 5, 2014 Zydus Pharmaceuticals USA Inc 5400 bottles units

FDA Drug Class II Terminated

PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only. Manufactured by: Cadila Healthcared Ltd., India. Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534. ND

May 8, 2014 Zydus Pharmaceuticals USA Inc 10,200 bottles units

FDA Drug Class I Terminated

Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534,

May 13, 2013 Zydus Pharmaceuticals USA Inc 960 Bottles units

FDA Drug Class II Terminated

Venlafaxine Hydrochloride Tablets, 75 mg*, 100-count tablets per bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA Inc., Pennington,

March 5, 2013 Zydus Pharmaceuticals USA Inc 13,320 bottles units

FDA Drug Class II Terminated

Metformin Hydrochloride Tablets, USP, 1000 mg, Rx only, 1000 count tablets per Bottle, Manufactured by: Cadila Healthcare LTD. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Penning

March 14, 2012 Zydus Pharmaceuticals USA Inc 1176 Bottles units