November 2019 FDA Recall Valganciclovir Hydrochloride For Oral by Teva Pharmaceuticals Usa, Inc.
D-0518-2020 - Presence of foreign substance

This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa, Inc. on November 4, 2019 for the product Valganciclovir Hydrochloride For Oral. The FDA reported the reason for recall as presence of foreign substance. The product was distributed in Product was distributed to wholesalers/distributors throughout the United States. and the recall is currently terminated.

Recall Number: D-0518-2020

Reason for Recall
Presence of foreign substance: Brown/black particles found during stability testing.
Initiated
11-04-2019
Reported
11-27-2019
Quantity
3,623 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84242
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Teva Pharmaceuticals USA, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to wholesalers/distributors throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-17-2020
Product Description About Product Description
Full technical description of the product.
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

0591-2579-20 Valganciclovir Hydrochloride For Oral