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Recall Observatory FDA recall evidence

Drug product

All sterile products within expiry

D-0012-2015

July 18, 2014

Class II

Product summary

Firm
Unique Pharmaceutical, Ltd
Event
Event 68841
Status
Terminated
Classification
Class II
Quantity
325,225 units (syringes, vials, bags)
Official record key
drug-enforcement:D-0012-2015

Official wording

Reason: Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products intended to be sterile.

Code information: All Lots

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Sterility