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
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
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.