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Recall Observatory FDA recall evidence

Drug product

HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3365-11 (carton) and 0409-3365-01(vial)

D-1167-2017

August 22, 2017

Class II

Product summary

Firm
Pfizer Inc.
Event
Event 77956
Status
Terminated
Classification
Class II
Quantity
115,370 vials
Official record key
drug-enforcement:D-1167-2017

Official wording

Reason: Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.

Code information: Lot: 760853A

Distribution pattern: United States Nationwide (including Puerto Rico) and Singapore

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of sterility