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Recall Observatory FDA recall evidence

Drug product

B-COMPLEX 110 INJECTABLE, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0212-3

D-0941-2020

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-0941-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 07022019+52584, 07022019+52579, Exp 3/29/2020; 08012019+52780, 08012019+52782, Exp 4/28/2020; 11262019+53288, Exp 8/23/2020

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