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Recall Observatory FDA recall evidence

Drug product

Vancomycin Hydrochloride for Injection, USP, 500 mg Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4332-01.

D-0387-2015

October 06, 2014

Class II

Product summary

Firm
Hospira Inc.
Event
Event 69573
Status
Terminated
Classification
Class II
Quantity
200 vials
Official record key
drug-enforcement:D-0387-2015

Official wording

Reason: Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.

Code information: One shipment of Lot #: 34-366-8E02; Exp 1OCT2015 to The Harvard Drug Group, Livonia, MI

Distribution pattern: Distribution limited to one shipment to The Harvard Drug Group, Livonia, MI for the lots of Vancomycin 500 mg, Ketorolac tromethamine 60 mg/2 mL (30 mg/mL), and Propofol 1% 200 mg/20 mL (10 mg/mL), these lots remained within the control of the distributor and were not further distributed. Distribution was Nationwide for the Vancomycin 1 g product.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.