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Recall Observatory FDA recall evidence

Drug product

Ketorolac Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Single-dose Fliptop Vial, packaged in 25 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-3796-01.

D-0388-2015

October 06, 2014

Class II

Product summary

Firm
Hospira Inc.
Event
Event 69573
Status
Terminated
Classification
Class II
Quantity
100 vials
Official record key
drug-enforcement:D-0388-2015

Official wording

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

Code information: One shipment of Lot #: 34-540-DK; 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.