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Recall Observatory FDA recall evidence

Drug product

B-Complex, Thiamine HCI / Riboflavin / Niacinamide / Dexpanthenol / Pyridoxine HCI injection, 74/2/75/2/2 MG/ML, 30ML Sterile Multiple-Dose Vial, Rx only, AnazaoHealth, 7465 W Sunset Rd #1200, Las Vegas, NV 89113, NDC 72682-2230-3

D-0203-2024

November 22, 2023

Class II

Product summary

Firm
AnazaoHealth Corporation
Event
Event 93500
Status
Terminated
Classification
Class II
Quantity
5,707 vials
Official record key
drug-enforcement:D-0203-2024

Official wording

Reason: Presence of Particulate Matter.

Code information: Lots: 505075, Exp: 02/05/24; 505596, Exp: 02/06/24; 506155, Exp: 02/07/24; 508103, Exp: 02/13/24; 510837, Exp: 02/19/24; 512411, Exp: 02/20/24; 514856, Exp: 02/25/24; 515642, Exp: 02/28/24; 518309, Exp: 03/05/24; 524262, 524266, Exp: 03/12/24; 524909, Exp: 03/13/24; 526526, Exp: 03/16/24; 529204, Exp: 03/18/24; 530858, Exp: 03/20/24; 535766, Exp: 03/30/24

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter