Glycopyrrolate Injection, Solution
FDA Recall NDC 55150-293
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 55150-293). A significant event, classified as Class III, was initiated on Feb 07, 2020 by Auromedics Pharma Llc. The reported reason for this action was: "Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples)."
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
February 2020 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Terminated
Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
Feb 07, 2020
Feb 26, 2020
4600 Vials
Recall Profile & Regulatory Data
Event ID
84927
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
AuroMedics Pharma LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Ohio, Louisiana, Mississippi
Termination Date
Mar 08, 2023
Product Description
Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intravenous Use, Not for Use in Newborns, Contains Benzyl Alcohol, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ, 08520, Made in India, NDC 55150-295-20.
Batch or Lot Expiration Information
Lot# CGP190001-A, Exp. 07/31/2020
Affected Packages Involved in this Recall
55150-292-01Product
55150-293-02Product
55150-294-05Product
55150-295-20Product
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.
