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Recall Observatory FDA recall evidence

Drug product

CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11

D-928-2013

August 13, 2013

Class II

Product summary

Firm
Teva Pharmaceuticals USA, Inc.
Event
Event 65959
Status
Terminated
Classification
Class II
Quantity
780 vials
Official record key
drug-enforcement:D-928-2013

Official wording

Reason: Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.

Code information: Lot 31314458B, 31314459B exp.08/14, 31315794 exp. 10/14, 31315982B exp.11/14

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility