PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: February 25, 2015 Initiated: October 6, 2014 #D-0388-2015

Product Description

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.

Details

Recalling Firm
Hospira Inc.
Units Affected
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.
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
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.. Recalled by Hospira Inc.. Units affected: 100 vials.
Why was this product recalled?
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 25, 2015. Severity: Moderate. Recall number: D-0388-2015.