FDAClass IIFebruary 3, 2016

Hydromorphone HCL recall: Sterility Concern

HYDROMORPHONE HCL, Packaged as a) 2.5MG in 1ML Syringes, b) 150MG in 75ML Homepumps, c) 125MG in 125ML Homepumps, d) 250MG in 125ML Homepumps, e)…

Why was Hydromorphone HCL 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) 29-Sep-15 b) 30-Sep-15 c) 1-Oct-15, d) 30-Sep-15, e) 30-Sep-15

Product
HYDROMORPHONE HCL, Packaged as a) 2.5MG in 1ML Syringes, b) 150MG in 75ML Homepumps, c) 125MG in 125ML Homepumps, d) 250MG in 125ML Homepumps, e)…
Recalling firm
Sentara Enterprises
Quantity
a) 42 Syringes, b) 6 Bags, c) 4 Bags, d) 4 Bags, e) 1 Bag
Distribution
U.S. Including: VA, NC
Recall date
February 3, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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