Drug Enforcement D-0870-2023

Labeling: Label Mix-up

Status

Terminated

Classification

Class III

Report Date

June 14, 2023

Termination Date

February 27, 2024

Product Information

Product description
GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC, Mukilteo, WA 98275, NDC 51662-1487-3
Product quantity
9 boxes of 25 vials
Reason for recall
Labeling: Label Mix-up
Recall initiation reason
Initial firm notification
Letter
Distribution pattern
Distributed in TX, AZ and CA only

Location & Firm

Recalling firm
HF Acquisition Co LLC
Address
11629 49th Pl W

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-0870-2023
Event ID
92468
Recall initiation date
June 6, 2023
Center classification date
June 8, 2023
Code info
Lot #: 2205095.1, Exp. Date 7/31/2024
More code info