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Recall Observatory FDA recall evidence

Drug product

Nicotinamide Adenine Dinucleotide (PF) Injection, NICOTINAMIDE ADENINE DINUCLEOTIDE (PF) 50 MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 10 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0306-1

D-0977-2020

January 15, 2020

Class II

Product summary

Firm
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Event
Event 84978
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0977-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 08282019+52850, Exp 1/24/2020; 10102019+53094, Exp 2/28/2020; 10312019+53174, Exp 3/28/2020

Distribution pattern: U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility