FDAClass IFebruary 23, 2022

HYDROmorphone HCl PF 10 mg/50 mL recall: Labeling Error

HYDROmorphone HCl PF 10 mg/50 mL (0.2mg/mL) in NaCl, 50 mL in 50 mL Single Dose Syringe, Rx only, STAQ Pharma, Inc., Denver, CO 80239, NDC…

Why was HYDROmorphone HCl PF 10 mg/50 mL recalled?

Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A

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 Number: 21104221A, Expiration date: 05-22-2022

Product
HYDROmorphone HCl PF 10 mg/50 mL (0.2mg/mL) in NaCl, 50 mL in 50 mL Single Dose Syringe, Rx only, STAQ Pharma, Inc., Denver, CO 80239, NDC…
Recalling firm
STAQ Pharma, Inc.
Quantity
905 Syringes
Distribution
CO, OH, and TX.
Recall date
February 23, 2022
Classification
Class I
Status
Terminated
Agency
FDA (drug)
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