Acyclovir Tablet
FDA Recall NDC 50268-062
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 Acyclovir (NDC 50268-062). A significant event, classified as Class II, was initiated on Feb 09, 2018 by Avpak. The reported reason for this action was: "Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities."
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 2018 Class II Recall: Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities.
Recall Number
Class II Terminated
Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities.
Feb 09, 2018
Mar 07, 2018
630 cartons
Recall Profile & Regulatory Data
Event ID
79194
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Apace KY LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 10, 2019
Product Description
Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 50268-061-11] per carton [NDC 50268-061-15], Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478
Batch or Lot Expiration Information
Lot# Lot: 19900, exp 05/2019
Affected Packages Involved in this Recall
50268-061-11Product
50268-061-15Product
50268-062-11Product
50268-062-15Product
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.
