Drug Enforcement D-0284-2024

Subpotent Drug and Failed Impurities/Degradation Specifications

Status

Terminated

Classification

Class II

Report Date

February 7, 2024

Termination Date

August 27, 2024

Product Information

Product description
Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-659-06
Product quantity
165,60 bottles
Reason for recall
Subpotent Drug and Failed Impurities/Degradation Specifications
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites.

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-0284-2024
Event ID
93753
Recall initiation date
January 5, 2024
Center classification date
January 30, 2024
Code info
A200817 exp 1/2024
More code info
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