FDA recall D-0870-2023

HF Acquisition Co LLC · Class III · drug

Product

GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC, Mukilteo, WA 98275, NDC 51662-1487-3

Reason for recall

Labeling: Label Mix-up

Distribution

Distributed in TX, AZ and CA only

Key facts

Status
Terminated
Initiation date
2023-06-06
Report date
2023-06-14
Termination date
2024-02-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mukilteo, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0870-2023