FDAClass IIFebruary 3, 2016

Dobutamine HCL in D5w recall: Sterility Concern

DOBUTAMINE HCL in D5W, Packaged as a) 240MG in 60ML Homepumps and b) 1520MG in 380ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535…

Why was Dobutamine HCL in D5w recalled?

Lack of Assurance of Sterility: Product sterility cannot be guaranteed.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 30-Sep-15, b) 25-Sep-15

Product
DOBUTAMINE HCL in D5W, Packaged as a) 240MG in 60ML Homepumps and b) 1520MG in 380ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535…
Recalling firm
Sentara Enterprises
Quantity
a) 7 Bags, b) 4 Bags
Distribution
U.S. Including: VA, NC
Recall date
February 3, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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