Drug Enforcement D-1536-2022

Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.

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Status

Terminated

Classification

Class II

Report Date

September 21, 2022

Termination Date

January 31, 2024

Product Information

Product description
Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Nagpur- 441 108, India. NDC 68180-980-03
Product quantity
11,802 1000-count bottles
Reason for recall
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Product was distributed to major distributors/wholesalers nationwide.

Location & Firm

Recalling firm
Lupin Pharmaceuticals Inc.
Address
Harborplace Tower, 111 S Calvert St Fl 21st

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-1536-2022
Event ID
90859
Recall initiation date
September 13, 2022
Center classification date
September 15, 2022
Code info
Lot # Q201182, exp. date March 2024
More code info
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