Acyclovir Tablet
FDA Recall NDC 60505-5307
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 60505-5307). A significant event, classified as Class II, was initiated on Jul 17, 2013 by Apotex Corp.. The reported reason for this action was: "Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitrile rubber glove embedded within the tablets."
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 II Terminated
Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitrile rubber glove embedded within the tablets.
Jul 17, 2013
Dec 04, 2013
4,844 bottles
Recall Profile & Regulatory Data
Event ID
66807
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Apotex Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Aug 04, 2014
Product Description
Acyclovir Tablets USP 800 mg ,(NDC 60505-5307-1), Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp.,Weston, Florida 33326.
Batch or Lot Expiration Information
Lot# KF2199 Exp 07/15
Affected Packages Involved in this Recall
60505-5306-3Product
60505-5306-1Product
60505-5306-5Product
60505-5306-8Product
60505-5307-3Product
60505-5307-1Product
60505-5307-5Product
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.
