Guanfacine Extended-release Tablet, Extended Release
FDA Recall NDC 60505-3929
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 Guanfacine Extended-release (NDC 60505-3929). A significant event, classified as Class II, was initiated on Mar 31, 2021 by Apotex Corp.. The reported reason for this action was: "Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate
Mar 31, 2021
Apr 14, 2021
55620 bottles
Recall Profile & Regulatory Data
Event ID
87648
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Apotex Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-3928-1, UPC 3 60505 39281 0
Batch or Lot Expiration Information
Lot# : RX1662, RX1663, RX1664 Exp. 11/2022
Affected Packages Involved in this Recall
60505-3927-3Product
60505-3927-1Product
60505-3927-8Product
60505-3928-3Product
60505-3928-1Product
60505-3928-8Product
60505-3929-3Product
60505-3929-1Product
60505-3929-8Product
60505-3930-3Product
60505-3930-1Product
60505-3930-8Product
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.
