FDA recall D-0633-2022

STAQ Pharma, Inc. · Class I · 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.

Reason for recall

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

Distribution

CO, OH, and TX.

Key facts

Status: Terminated
Initiation date: 2022-02-03
Report date: 2022-02-23
Termination date: 2022-09-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Denver, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0633-2022