Drug Enforcement D-0443-2024

Failed Impurities/Degradation Specifications

Status

Terminated

Classification

Class III

Report Date

April 24, 2024

Termination Date

July 16, 2024

Product Information

Product description
Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-200-10
Product quantity
1,003 bottles
Reason for recall
Failed Impurities/Degradation Specifications
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
U.S. Nationwide

Location & Firm

Recalling firm
Novitium Pharma LLC
Address
70 Lake Dr

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

Codes & Dates

Recall number
D-0443-2024
Event ID
94255
Recall initiation date
March 25, 2024
Center classification date
April 13, 2024
Code info
Lot M23011A; Exp. 12/2024
More code info
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