Drug Enforcement D-0389-2024

Cross Contamination with Other Products:(mycophenolate mofetil).

Status

Terminated

Classification

Class III

Report Date

March 27, 2024

Termination Date

March 21, 2025

Product Information

Product description
Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufactured by: Novitium Pharma LLC., 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-201-20
Product quantity
3,940 1000-count bottles
Reason for recall
Cross Contamination with Other Products:(mycophenolate mofetil).
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

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-0389-2024
Event ID
94132
Recall initiation date
March 4, 2024
Center classification date
March 15, 2024
Code info
Lot #: M23172A, Exp 01/31/2025
More code info
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