Amneal Pharmaceuticals of New York, LLC.

FDA Drug Class II Completed

Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2.

March 25, 2024 Amneal Pharmaceuticals of New York, LLC. 2784 bottles units

FDA Drug Class I Terminated

Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC 69238-2261-7; (c)300 mL bottle, NDC 69238-2261-5; Rx only, Dis

March 21, 2024 Amneal Pharmaceuticals of New York, LLC. 821 bottles units

FDA Drug Class II Terminated

Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC# 69238-1273-6

February 13, 2024 Amneal Pharmaceuticals of New York, LLC. 46,037 Bottles units

FDA Drug Class II Terminated

Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad 382213, India, Distributed by: Amneal

January 15, 2024 Amneal Pharmaceuticals of New York, LLC. 858 bottles units

FDA Drug Class II Terminated

Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewate

December 26, 2023 Amneal Pharmaceuticals of New York, LLC. 21,452/100 count bottles units

FDA Drug Class II Terminated

Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10

October 27, 2023 Amneal Pharmaceuticals of New York, LLC. 9,263 100-count bottles units

FDA Drug Class II Terminated

Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC., Bridgewater, NJ 08807, NDC 65162-212-10.

May 30, 2023 Amneal Pharmaceuticals of New York, LLC. 9,056 bottles units

FDA Drug Class III Terminated

Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft Tissue Injection Only, Not for Intravenous Use, 1 mL Single Dose Vial, Manufactured by: Amneal

May 8, 2023 Amneal Pharmaceuticals of New York, LLC. 69,239 vials units

FDA Drug Class II Terminated

Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals, India, Distributed by: Amneal Pharmaceuticals, Bridgewater, NJ,

July 27, 2022 Amneal Pharmaceuticals of New York, LLC. 4,309 bottles units

FDA Drug Class II Terminated

Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-703-86

November 4, 2021 Amneal Pharmaceuticals of New York, LLC. 15,88 bottles units

FDA Drug Class II Terminated

Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-704-86

November 4, 2021 Amneal Pharmaceuticals of New York, LLC. 7,766 bottles units

FDA Drug Class II Ongoing

amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only, 500 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 388213, INDIA Distributed by: Amneal Phar

May 29, 2020 Amneal Pharmaceuticals of New York, LLC. N/A units

FDA Drug Class II Ongoing

amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 382213 India Distributed by: Amneal Pharm

May 29, 2020 Amneal Pharmaceuticals of New York, LLC. N/A units

FDA Drug Class II Ongoing

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Ph

May 29, 2020 Amneal Pharmaceuticals of New York, LLC. N/A units

FDA Drug Class II Ongoing

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg Rx only 100 Tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-01

May 29, 2020 Amneal Pharmaceuticals of New York, LLC. N/A units

FDA Drug Class II Ongoing

amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottles, Rx only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-05

May 29, 2020 Amneal Pharmaceuticals of New York, LLC. N/A units

FDA Drug Class II Ongoing

amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-BULK

May 29, 2020 Amneal Pharmaceuticals of New York, LLC. N/A units

FDA Drug Class II Ongoing

amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-BULK

May 29, 2020 Amneal Pharmaceuticals of New York, LLC. N/A units

FDA Drug Class II Ongoing

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-10

May 29, 2020 Amneal Pharmaceuticals of New York, LLC. N/A units

FDA Drug Class II Ongoing

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceut

May 29, 2020 Amneal Pharmaceuticals of New York, LLC. N/A units

FDA Drug Class II Ongoing

amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg Rx Only 90 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharma

May 29, 2020 Amneal Pharmaceuticals of New York, LLC. N/A units

FDA Drug Class II Ongoing

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-90

May 29, 2020 Amneal Pharmaceuticals of New York, LLC. N/A units

FDA Drug Class II Ongoing

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 count bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-01

May 29, 2020 Amneal Pharmaceuticals of New York, LLC. 192 units

FDA Drug Class II Terminated

Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC Bridgewater, NJ 08807 NDC 60846-301-15

April 15, 2020 Amneal Pharmaceuticals of New York, LLC. 11258 bottles units

FDA Drug Class I Terminated

Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Branchburg, NJ 08876. Distributed by: Amneal Pharmaceuticals, Glasgow, KY 42141. NDC 65162-687-

August 3, 2017 Amneal Pharmaceuticals of New York, LLC. 136376 bottles units

FDA Drug Class II Terminated

Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label, NDC 65162-212-11 --- Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distribute

August 17, 2013 Amneal Pharmaceuticals of New York, LLC. 895 - 1000 count bottles units