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Recall Observatory FDA recall evidence

Drug product

All sterile drugs compounded between 2/21/14 and 2/24/14.

D-0003-2015

February 26, 2014

Class II

Product summary

Firm
New England Home Therapies, Inc
Event
Event 67687
Status
Terminated
Classification
Class II
Quantity
87 Products
Official record key
drug-enforcement:D-0003-2015

Official wording

Reason: Lack of Assurance of Sterility: All compounded products.

Code information: Expiration dates between 3/5/14 and 3/10/14.

Distribution pattern: US: New England

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility