← FDA ENFORCEMENT
D-0443-2024Class III

Novitium Pharma LLC

Recalling firm
Novitium Pharma LLC
Product type
Drug
Status
Terminated
Report date
2024-04-24
Distribution
U.S. Nationwide
Firm state
NJ
Product quantity
1,003 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Failed Impurities/Degradation Specifications

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

Code / lot info

Lot M23011A; Exp. 12/2024

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.