Valganciclovir Hydrochloride For Oral Powder, For Solution
FDA Recall NDC 0591-2579
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 Valganciclovir Hydrochloride For Oral (NDC 0591-2579). A significant event, classified as Class II, was initiated on Nov 04, 2019 by Actavis Pharma, Inc.. The reported reason for this action was: "Presence of foreign substance: Brown/black particles found during stability testing."
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 foreign substance: Brown/black particles found during stability testing.
Nov 04, 2019
Nov 27, 2019
3,623 bottles
Recall Profile & Regulatory Data
Event ID
84242
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to wholesalers/distributors throughout the United States.
Termination Date
Nov 17, 2020
Product Description
Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL (3.4 fl. oz.) bottle, Rx only, Manufactured for: Actavis Laboratories FL. Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-2579-20
Batch or Lot Expiration Information
Lot# : CBFCN, CBHFG, Exp 05/2020
Affected Packages Involved in this Recall
0591-2579-20Product
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.
