June 2023 FDA Recall Glycopyrrolate by Hf Acquisition Co Llc
D-0870-2023 - Labeling

This Class III drug recall was voluntarily initiated by Hf Acquisition Co Llc on June 6, 2023 for the product Glycopyrrolate. The FDA reported the reason for recall as labeling. The product was distributed in Distributed in TX, AZ and CA only and the recall is currently terminated.

Recall Number: D-0870-2023

Reason for Recall
Labeling: Label Mix-up
Initiated
06-06-2023
Reported
06-14-2023
Quantity
9 boxes of 25 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92468
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
HF Acquisition Co LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed in TX, AZ and CA only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-27-2024
Product Description About Product Description
Full technical description of the product.
GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC, Mukilteo, WA 98275, NDC 51662-1487-3

Batch or Lot Expiration Information

Lot# : 2205095.1, Exp. Date 7/31/2024

Affected Packages Involved in this Recall

51662-1487-1 Glycopyrrolate
51662-1487-2 Glycopyrrolate
51662-1487-3 Glycopyrrolate