FDAClass IIJuly 25, 2018

HYDROmorphone 1 mg/mL recall: Sterility Concern

HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 30 mg, 0.9% Sodium Chloride (USP) QS 30 mL) Volume: 30mL. Single dose syringe. Avella of Houston, 9265…

Why was HYDROmorphone 1 mg/mL recalled?

Lack of Assurance of Sterility: Potential leakage of bags.

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?

Lot #: 3/15/18 0954 22263M, BUD 6/13/2018.

Product
HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 30 mg, 0.9% Sodium Chloride (USP) QS 30 mL) Volume: 30mL. Single dose syringe. Avella of Houston, 9265…
Recalling firm
Avella of Deer Valley, Inc. Store 38
Quantity
480 syringes
Distribution
Nationwide in the USA
Recall date
July 25, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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