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Lupin Pharmaceuticals Inc.

7 ongoing recalls and 116 historical records

Based on the official records currently available to Public Health Trace, 7 recalls naming Lupin Pharmaceuticals Inc. are currently shown as ongoing. The other 116 records below are historical.

Public Health Trace has 123 recalls naming Lupin Pharmaceuticals Inc. as the recalling firm, republished from official FDA and USDA sources.

Recall records - 123 total

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
20181
201925
202019
202111
202214
20235
202414
20257
20264
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FDA Recall TerminatedTerminated: April 10, 2017Historical recordClass III

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

by Lupin Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications; Impurity A
Published
April 12, 2017
Distribution
Nationwide

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FDA Recall TerminatedTerminated: August 7, 2017Historical recordClass III

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, INDIA, NDC 68180-517-03.

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Published
September 28, 2016
Distribution
All product distributed domestically in…

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FDA Recall TerminatedTerminated: August 7, 2017Historical recordClass III

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 21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA.

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Published
September 28, 2016
Distribution
All product distributed domestically in…

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FDA Recall TerminatedTerminated: June 1, 2017Historical recordClass III

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, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 India, a) NDC 68180-519-01, b) 68180-519-30

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Published
July 6, 2016
Distribution
Nationwide

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FDA Recall TerminatedTerminated: August 14, 2017Historical recordClass III

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 Pradesh) India; Regd. Office: 159, CST Road Kalina, Santacruz (E), Mumbai- 400 098, (Maharashtra) India.

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.
Published
June 8, 2016
Distribution
Nationwide

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FDA Recall TerminatedTerminated: August 14, 2017Historical recordClass III

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 Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-633-01.

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Published
June 8, 2016
Distribution
Nationwide

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FDA Recall TerminatedTerminated: August 14, 2017Historical recordClass III

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 Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-633-01.

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Published
June 8, 2016
Distribution
Nationwide

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FDA Recall TerminatedTerminated: August 14, 2017Historical recordClass III

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 Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Published
June 8, 2016
Distribution
Nationwide

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FDA Recall TerminatedTerminated: August 14, 2017Historical recordClass III

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 Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Published
June 8, 2016
Distribution
Nationwide

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FDA Recall TerminatedTerminated: May 12, 2015Historical recordClass III

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 Lupin Limited Mumbai 400 058 India, NDC 27437-207-03.

by Lupin Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
Published
April 9, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: May 12, 2015Historical recordClass III

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 Lupin Limited Mumbai 400 058 India, NDC 27437-207-02.

by Lupin Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
Published
April 9, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: May 11, 2016Historical recordClass II

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 68180-556-09

by Lupin Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
Published
January 22, 2014
Distribution
Nationwide

View recall →

Some FDA recall records on this page come from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.

This page lists recalls that name Lupin Pharmaceuticals Inc. as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.

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