Glycopyrrolate Tablet
FDA Recall NDC 50268-363
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 50268-363). A significant event, classified as Class II, was initiated on Dec 22, 2022 by Avpak. The reported reason for this action was: "Failed impurities/degradation specifications: Out of specification for unknown impurities."
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
December 2022 Class II Recall: Failed impurities/degradation specifications
Recall Number
Class II Completed
Failed impurities/degradation specifications: Out of specification for unknown impurities.
Dec 22, 2022
Jan 04, 2023
1237 cartons
Recall Profile & Regulatory Data
Event ID
91390
Classification
Class II
Enforcement Status
Completed
Recalling Firm
AVKARE LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Product Description
Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15
Batch or Lot Expiration Information
Lot# : 43313, 43342, Exp 12/2023
Affected Packages Involved in this Recall
50268-363-11Product
50268-363-15Product
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.
