Drug recall D-0388-2015

Class II Terminated reported Feb 25, 2015

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.

Reason for recall

Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.

Lots and codes

One shipment of Lot #: 34-540-DK; Exp 1OCT2015 to The Harvard Drug Group, Livonia, MI

Recall details

Recalling firm
Hospira Inc., Lake Forest, IL
Quantity
100 vials
Distribution
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.
Type
Voluntary: Firm initiated
Recall initiated
October 6, 2014
Terminated
December 15, 2016

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