Drug Enforcement D-0100-2023

Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.

Status

Terminated

Classification

Class II

Report Date

January 18, 2023

Termination Date

January 31, 2024

Product Information

Product description
Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin Pharmaceuticals Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India. NDC 68180-659-06
Product quantity
16,056 30 count bottles
Reason for recall
Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Distributed Nationwide in the USA

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-0100-2023
Event ID
91295
Recall initiation date
December 12, 2022
Center classification date
January 9, 2023
Code info
Lot # A200171, Exp 12/2023
More code info
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