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Lupin Pharmaceuticals Inc.

Recalls

Recalls by year

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

Recalls by year
YearRecalls
20182
201925
202019
202111
202214
20235
202414
20257
20263
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FDA Recall Terminated Historical 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 Terminated Historical 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 Terminated Historical 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 Terminated Historical 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 Terminated Historical 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 Terminated Historical 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 Terminated Historical 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 Terminated Historical 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 Terminated Historical 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 Terminated Historical 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 Terminated Historical 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

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FDA Recall Terminated Historical recordClass II

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 68180-557-09

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

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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.