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Recall Observatory FDA recall evidence

Drug 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: 73177-0104-05.

D-0633-2022

February 03, 2022

Class I

Product summary

Firm
STAQ Pharma, Inc.
Event
Event 89550
Status
Terminated
Classification
Class I
Quantity
905 Syringes
Official record key
drug-enforcement:D-0633-2022

Official wording

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

Code information: Lot Number: 21104221A, Expiration date: 05-22-2022

Distribution pattern: CO, OH, and TX.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label Mix up