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Recall Observatory FDA recall evidence

Drug product

0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 10 mL, Single-Dose Vial, NDC 0409-9045-01, Hospira, Inc., Lake Forest, IL 60045

D-66295-001

September 05, 2013

Class II

Product summary

Firm
Hospira Inc.
Event
Event 66295
Status
Terminated
Classification
Class II
Quantity
187,150 vials
Official record key
drug-enforcement:D-66295-001

Official wording

Reason: Lack of Assurance of Sterility; potential for vial breakage

Code information: Lot 17-400-EV* and 17-401-EV * Note: the lot number may be followed by 01

Distribution pattern: Nationwide and Guam and Abu Dhabi

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility