Glycopyrrolate Injection
FDA Recall NDC 51662-1487
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Glycopyrrolate (NDC 51662-1487). A significant event, classified as Class III, was initiated on Jun 06, 2023 by Hf Acquisition Co Llc, Dba Healthfirst. The reported reason for this action was: "Labeling: Label Mix-up"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Labeling: Label Mix-up
Jun 06, 2023
Jun 14, 2023
9 boxes of 25 vials
Recall Profile & Regulatory Data
Event ID
92468
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
HF Acquisition Co LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed in TX, AZ and CA only
Termination Date
Feb 27, 2024
Product Description
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
51662-1487-1Product
51662-1487-2Product
51662-1487-3Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
