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Recall Observatory FDA recall evidence

Drug product

Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic, Fliptop Vial, C-IV, Rx Only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-3213-12

D-927-2013

August 16, 2013

Class II

Product summary

Firm
Hospira Inc.
Event
Event 66104
Status
Terminated
Classification
Class II
Quantity
72,300 vials
Official record key
drug-enforcement:D-927-2013

Official wording

Reason: Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials.

Code information: Lot: 23-505-EV, Exp. 11/14

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility