Lupin Pharmaceuticals Inc.

FDA Drug Class II Terminated

Lupin Cefdinir powder for Oral Suspension USP, 250 mg/5 mL in (a) 60 mL packs ( NDC 68180-723-20) and (b) 100 mL packs ( 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimor

March 27, 2018 Lupin Pharmaceuticals Inc. 40,824 bottles units

FDA Drug Class III Terminated

Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Goa 403

November 21, 2017 Lupin Pharmaceuticals Inc. 111,648 units units

FDA Drug Class III Terminated

Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 4

June 22, 2017 Lupin Pharmaceuticals Inc. 12480 bottles units

FDA Drug Class III Terminated

Famotidine for Oral Suspension USP, 40 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Goa 403 722 INDIA, NDC

May 2, 2017 Lupin Pharmaceuticals Inc. 12,888 bottles units

FDA Drug Class III Terminated

Lisinopril Tablets USP, 40 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775

April 6, 2016 Lupin Pharmaceuticals Inc. 5,880 bottles units

FDA Drug Class III Terminated

Lisinopril Tablets USP, 30 mg, packaged in a) 500-count bottles (NDC 68180-516-02) and b) 100-count bottles (NDC 68180-516-01); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 2

April 6, 2016 Lupin Pharmaceuticals Inc. 20,556 bottles units

FDA Drug Class III Terminated

Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 5000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, M

April 4, 2016 Lupin Pharmaceuticals Inc. 59,520 Bottles units

FDA Drug Class III Terminated

Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep-462 046, (Madhya P

March 11, 2016 Lupin Pharmaceuticals Inc. 741.171 kg units

FDA Drug Class III Terminated

Ceftriaxone for Injection USP, 250 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-611-01), and b) 10-count Vials per box (NDC 68180-611-10), Rx only, Manufactured for: Lupin Phar

March 11, 2016 Lupin Pharmaceuticals Inc. 15408 vials units

FDA Drug Class III Terminated

Ceftriaxone for Injection USP, 1 g, Single Use Vial (NDC 68180-633-01) packaged in 10-count Vials per box (NDC 68180-633-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert

March 11, 2016 Lupin Pharmaceuticals Inc. 30586 vials units

FDA Drug Class III Terminated

Ceftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-622-01), and b) 10-count Vials per box (NDC 68180-622-10), Rx only, Manufactured for: Lupin Phar

March 11, 2016 Lupin Pharmaceuticals Inc. 7908 vials units

FDA Drug Class III Terminated

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

March 11, 2016 Lupin Pharmaceuticals Inc. 570 vials units

FDA Drug Class III Terminated

Quinapril Tablets USP 5 mg, 90 count bottles, Lupin Pharmaceuticals, Inc., Baltimore, MD --- NDC 68180-556-09

December 7, 2015 Lupin Pharmaceuticals Inc. 15,168 bottes units

FDA Drug Class III Terminated

Suprax, Cefixime for Oral Suspension USP 500 mg/5 ml, 10mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lu

January 27, 2014 Lupin Pharmaceuticals Inc. 4,038 bottles units

FDA Drug Class III Terminated

Suprax, Cefixime for Oral Suspension USP, 500 mg/5 ml, 20 mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by

January 27, 2014 Lupin Pharmaceuticals Inc. 5,172 bottles units

FDA Drug Class II Terminated

Quinapril Tablets USP, 10 mg, 90 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 United States Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-55

September 17, 2013 Lupin Pharmaceuticals Inc. 22, 896 bottles units

FDA Drug Class II Terminated

Quinapril Tablets USP, 5 mg, 90 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 United States Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-556

September 17, 2013 Lupin Pharmaceuticals Inc. 30,264 bottles units

FDA Drug Class III Terminated

Ethambutol Hydrochloride Tablets USP, 400 mg, 100-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Manufactured by: Lupin Limited, Mumbai

February 22, 2013 Lupin Pharmaceuticals Inc. 4896 bottles units

FDA Drug Class III Terminated

Suprax (cefixime for oral suspension) USP, 100 mg/5 mL, 50 mL bottles (when reconstituted), Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by

January 31, 2013 Lupin Pharmaceuticals Inc. 64,368 bottles units