Lupin Pharmaceuticals Inc.

FDA Drug Class III Terminated

Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after constitution), Rx only, Manufactured for:Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Li

January 21, 2021 Lupin Pharmaceuticals Inc. 46,479 bottles units

FDA Drug Class II Terminated

Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) chewable,1 mg/0.02 mg/75 mg, Rx Only, Provides 24 days of active therapy, Pouch Contains one wallet of

July 21, 2020 Lupin Pharmaceuticals Inc. 560,922 Pouches units

FDA Drug Class II Terminated

Lisinopril Tablets USP, 10 mg, 1000 count bottles, Manufactured by: Lupin Limited, Nagpur INDIA, For BluePoint Laboratories NDC 68001-334-08

July 17, 2020 Lupin Pharmaceuticals Inc. 11,688 bottles units

FDA Drug Class II Terminated

Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-338-01

July 7, 2020 Lupin Pharmaceuticals Inc. 64,344 bottles units

FDA Drug Class II Terminated

Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-337-07

July 7, 2020 Lupin Pharmaceuticals Inc. 273,060 bottles units

FDA Drug Class II Terminated

Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-336-07

July 7, 2020 Lupin Pharmaceuticals Inc. 59,568 bottles units

FDA Drug Class II Terminated

Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-339-09

July 7, 2020 Lupin Pharmaceuticals Inc. 95,886 bottles units

FDA Drug Class II Terminated

Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India,

July 2, 2020 Lupin Pharmaceuticals Inc. 35,928 bottles units

FDA Drug Class II Terminated

Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD Manufactured by: Lupin Limited Goa INDIA (NDC 68180-

June 11, 2020 Lupin Pharmaceuticals Inc. 6,540 bottles units

FDA Drug Class II Terminated

Lisinopril Tablets, USP, 5 mg, Rx Only, 1000-count bottle, Manufactured for: Lupin Pharmaceuticals Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Nagpur - 441 108, India, NDC 68180-513-03.

May 28, 2020 Lupin Pharmaceuticals Inc. 4,224 bottles units

FDA Drug Class II Terminated

Lisinopril Tablets USP, 20 mg, 1000-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore MD 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, India. NDC 68180-0

April 20, 2020 Lupin Pharmaceuticals Inc. 11,808 bottles units

FDA Drug Class II Terminated

Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Mandideep 462 046 INDIA, NDC

April 15, 2020 Lupin Pharmaceuticals Inc. 4,518 bottles units

FDA Drug Class II Terminated

Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-982-01

April 1, 2020 Lupin Pharmaceuticals Inc. 25,944 bottles units

FDA Drug Class III Terminated

Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP, 0.01 mg), packaged in 1 Wallet of 28 Tablets (NDC 68180-879-11), 3 Wallets of 28 Tablets Each

March 9, 2020 Lupin Pharmaceuticals Inc. 1,712 cartons units

FDA Drug Class II Terminated

Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05mg/0.03 mg, 0.075mg/0.04mg, and 0.125mg/0.03mg, packaged in 1 Wallet of 28 Tablets (NDC 68180-857-11), 3 Wallets of 28 Tablets Each per carton (ND

March 9, 2020 Lupin Pharmaceuticals Inc. 9,897 cartons units

FDA Drug Class II Terminated

Desoximetasone Topical Spray, 0.25%, 2.5 mg desoximetasone, 100 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD

February 19, 2020 Lupin Pharmaceuticals Inc. 876 bottles units

FDA Drug Class II Terminated

Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States. Manufactured by: Lupin Limit

February 12, 2020 Lupin Pharmaceuticals Inc. 6,294 bottles units

FDA Drug Class III Terminated

Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.025 mg; 0.215mg/0.025 mg and 0.250 mg/0.025 mg, Pack size - 3 x 28's wallets/carton, Rx Only, Distributed by Lupin Pharmaceu

January 10, 2020 Lupin Pharmaceuticals Inc. 34,080 boxes (3 wallets per carton, 80 cartons per box) units

FDA Drug Class II Terminated

Blisovi Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets 75mg), Rx Only, Distributed by: Lupin Pharmaceuticals Inc Baltimore, MD 21202, Manufactured for

December 26, 2019 Lupin Pharmaceuticals Inc. 41,863 cartons/3 wallets per carton units

FDA Drug Class III Terminated

Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5 mL bottle, Manufactured by: Lupin Limited, Pithampur (M.P.), INDIA, NDC: 68180-429-03.

December 13, 2019 Lupin Pharmaceuticals Inc. 2,130 bottles units

FDA Drug Class III Terminated

Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-count bottles (NDC 68180-249-09 and b) 500-count bottles (NDC 68180-249-02); Rx only, Manufactured for: Lupin Pharmaceuticals

December 10, 2019 Lupin Pharmaceuticals Inc. 3,726 bottles units

FDA Drug Class III Terminated

Cephalexin for Oral Suspension USP, 250 mg/5mL, 200 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, Maryland 21202, United States, Manufactured b

November 1, 2019 Lupin Pharmaceuticals Inc. 28,254 bottles units

FDA Drug Class III Terminated

Cefdinir for Oral Suspension USP, 250 mg/5mL,100 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep

November 1, 2019 Lupin Pharmaceuticals Inc. 30,516 bottles units

FDA Drug Class III Terminated

Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-722-20), b) 100 mL bottle (NDC 68180-722-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Ma

November 1, 2019 Lupin Pharmaceuticals Inc. a) 4074 bottles b) 30,300 bottles units

FDA Drug Class II Terminated

Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg, 500-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pitham

July 19, 2019 Lupin Pharmaceuticals Inc. 11,832 bottles units

FDA Drug Class III Terminated

Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithamp

July 17, 2019 Lupin Pharmaceuticals Inc. 33,939 tubes units

FDA Drug Class II Terminated

Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle, Rx only, Manufactured by for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by: Lupin Limited, Pithampur, I

July 17, 2019 Lupin Pharmaceuticals Inc. 39,216 bottles units

FDA Drug Class III Terminated

Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL Bottle, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, United States, Manufactured b

July 11, 2019 Lupin Pharmaceuticals Inc. 17,238 bottles units

FDA Drug Class II Terminated

Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025 mg) and Ferrous Fumarate, Chewable Tablets, Rx Only, Distributed by: Lupin Pharmaceuticals, Inc. Baltimore, MD - 21202 Ma

July 2, 2019 Lupin Pharmaceuticals Inc. 12938 units units

FDA Drug Class II Terminated

Cefdinir for Oral Suspension USP, 250mg/5mL, Powder for oral suspension, 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 20201, Manufactured by: Lupin Limited

May 23, 2019 Lupin Pharmaceuticals Inc. 18,408, 60 mL bottles units

FDA Drug Class III Terminated

Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by : Lupin Limited, Goa, INDIA -- NDC 68180-198-06

April 1, 2019 Lupin Pharmaceuticals Inc. 12,504 bottles units

FDA Drug Class II Terminated

Fayosim (levonorgestrel and ethinyl estradiol) tablets USP, (0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg) and ethinyl estradiol tablets USP, (0.01 mg), packaged in 1 Extended-Cycle Wallet of 91

March 22, 2019 Lupin Pharmaceuticals Inc. 12,464 cartons units

FDA Drug Class III Terminated

Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.)

March 13, 2019 Lupin Pharmaceuticals Inc. 3,200 bottles units

FDA Drug Class III Terminated

Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01.

February 26, 2019 Lupin Pharmaceuticals Inc. 674,628 bottles units

FDA Drug Class III Terminated

Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and b) 100-count (NDC 68180-469-01) bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202;

February 13, 2019 Lupin Pharmaceuticals Inc. 44,640 bottles units

FDA Drug Class III Terminated

Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 Manufactured by: lupin Limited Pithampur (M.P.) 454 77

February 1, 2019 Lupin Pharmaceuticals Inc. 43,860 3ml bottles units

FDA Drug Class III Terminated

Bimatoprost Ophthalmic Solution 0.03%, packaged in a) 5 mL (NDC 68180-429-02) and b) 7.5 mL (NDC 68180-429-03) bottles, Rx only, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA.

January 28, 2019 Lupin Pharmaceuticals Inc. 9,930 bottles units

FDA Drug Class II Terminated

Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited Mandideep 462 046 India --- NDC 68180-441-

January 9, 2019 Lupin Pharmaceuticals Inc. 14,400 bottles units

FDA Drug Class II Terminated

Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India ---- N

January 7, 2019 Lupin Pharmaceuticals Inc. 7,215 bottles units

FDA Drug Class II Terminated

Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured

January 2, 2019 Lupin Pharmaceuticals Inc. 287,784 bottles units

FDA Drug Class II Terminated

Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)100mL (NDC 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured

January 2, 2019 Lupin Pharmaceuticals Inc. 287,784 bottles units

FDA Drug Class I Terminated

Ceftriaxone for Injection USP, 250 mg, packaged in a) one Single Use Vial (NDC 68180-611-01) and b) 10 Single Use Vials per box (NDC 68180-611-10); Rx only, Manufactured for: Lupin Pharmaceuticals, In

December 20, 2018 Lupin Pharmaceuticals Inc. a) 12,000 vials; b) 11,763 boxes units

FDA Drug Class I Terminated

Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-01) and b) 10 Single Use Vials per box (NDC 68180-622-10); Rx only, Manufactured for: Lupin Pharmaceuticals, In

December 20, 2018 Lupin Pharmaceuticals Inc. a) 8,000 vials; b) 32,045 boxes units

FDA Drug Class I Terminated

Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 68180-644-01) per box, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 2

December 20, 2018 Lupin Pharmaceuticals Inc. 3,792 boxes units

FDA Drug Class I Terminated

Ceftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 68180-633-01) and b) 10 Single Use Vials per box (NDC 68180-633-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc.,

December 20, 2018 Lupin Pharmaceuticals Inc. a) 35,000 vials; b) 112,641 boxes units

FDA Drug Class III Terminated

Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.)

October 9, 2018 Lupin Pharmaceuticals Inc. 6,752 bottles units

FDA Drug Class II Terminated

Lisinopril Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202, NDC 68180-980-03

August 13, 2018 Lupin Pharmaceuticals Inc. 11,706 bottles units

FDA Drug Class III Terminated

Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.)

July 26, 2018 Lupin Pharmaceuticals Inc. 13,896 bottles units

FDA Drug Class II Terminated

My Way (levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manu

May 17, 2018 Lupin Pharmaceuticals Inc. 43,640 cartons units

FDA Drug Class II Terminated

My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, GAVIS Pharmaceuticals, A Lupin Group Company; Mfg. for Lupin Pharmaceutic

May 17, 2018 Lupin Pharmaceuticals Inc. 43,922 cartons units