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Recall Observatory FDA recall evidence

Drug product

All Non Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on their website at www.neccrx.com

D-053-2013

October 06, 2012

Class II

Product summary

Firm
New England Compounding Center
Event
Event 63511
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
drug-enforcement:D-053-2013

Official wording

Reason: GMP Deviations

Code information: All lot codes

Distribution pattern: Nationwide Japan

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    GMP Deviations