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

Hospira Inc.: Vancomycin Hydrochloride for Injection, USP, 1 g Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-6533-01.

Is my product affected?

Vancomycin Hydrochloride for Injection, USP, 1 g Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-6533-01.

  • Brand VANCOMYCIN HYDROCHLORIDE

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

What happened

Hospira Inc. is recalling Vancomycin Hydrochloride for Injection, USP, 1 gram sterile powder in vials due to temperature abuse during transit. The affected product is Lot #35-315-DD with an expiration date of November 1, 2015. A total of 90,600 vials were distributed nationwide.

The recall occurred because the products experienced uncontrolled temperature excursions while being transported. The source document does not specify a remedy or required action for consumers who may have received this product.

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: 90,600 vials Lot/code info: Lot #: 35-315-DD; Exp 1NOV2015

Source

Official record: FDA (Drug enforcement) ↗

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

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