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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 I

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

by Lupin Pharmaceuticals Inc.

Reason
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Published
January 16, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

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

by Lupin Pharmaceuticals Inc.

Reason
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Published
January 16, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

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.) 454 775 INDIA, NDC 68180-943-11

by Lupin Pharmaceuticals Inc.

Reason
Defective Container: Repetitive complaints received indicating pump not working.
Published
October 31, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

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

by Lupin Pharmaceuticals Inc.

Reason
Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.
Published
August 22, 2018
Distribution
Product was distributed to distributors,…

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FDA Recall Terminated Historical recordClass III

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.) 454 775, INDIA, NDC 68180-422-01

by Lupin Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
Published
August 8, 2018
Distribution
Product was distributed throughout the U…

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FDA Recall Terminated Historical recordClass II

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; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454 775, INDIA, UPC 3 68180 85212 4.

by Lupin Pharmaceuticals Inc.

Reason
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Published
May 30, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

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 Pharmaceuticals, Inc., Baltimore, MD 21202, UPC 3 43386-622-31 3.

by Lupin Pharmaceuticals Inc.

Reason
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Published
May 30, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

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. Baltimore, Maryland 21202

by Lupin Pharmaceuticals Inc.

Reason
Superpotent Drug
Published
April 25, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

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 403 722 India, NDC 68180-295-06, UPC 368180295068

by Lupin Pharmaceuticals Inc.

Reason
Failed Dissolution Specification
Published
December 6, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

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 68180-150-01

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations
Published
September 13, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

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.) 454 775, India, NDC: 68180-647-06

by Lupin Pharmaceuticals Inc.

Reason
Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.
Published
July 19, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical 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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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.