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FDA (Drug enforcement)Recalled 2014-10-06closedclass ii

Hospira Inc.: 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.

Is my product affected?

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.

  • Brand KETOROLAC TROMETHAMINE

Check against the official notice below — it lists the full affected range.

What happened

Hospira Inc. is recalling Ketorolac Tromethamine Injection, USP 60 mg (30 mg/mL) in 2 mL single-dose vials due to temperature abuse during transit. The affected product is one shipment of 100 vials with Lot #34-540-DK with an expiration date of October 1, 2015, which was sent to The Harvard Drug Group in Livonia, Michigan.

The recalled medication remained under the control of the distributor and was not distributed further to other locations. The source document does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.

Details from the source

Reason for recall: Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. 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. Quantity: 100 vials Lot/code info: One shipment of Lot #: 34-540-DK; Exp 1OCT2015 to The Harvard Drug Group, Livonia, MI

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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