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Recall Observatory FDA recall evidence

Drug product

M.l.C./B5/B6 25 MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-0998-2016

May 17, 2016

Class II

Product summary

Firm
Well Care Compounding Pharmacy
Event
Event 74187
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0998-2016

Official wording

Reason: Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information: Lot #: 01272016:00@24, Exp.03/28/2016; Lot #: 03292016: 96@35, Exp. 05/24/2016

Distribution pattern: NV

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    GMP violations
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility