Recall: D-0518-2020

Class II - Potentially Harmful

Class IIClassification

2019-11-04Initiated

TerminatedStatus

Teva Pharmaceuticals USA, Inc.Firm

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

Reason

Presence of foreign substance: Brown/black particles found during stability testing.

Distribution

Product was distributed to wholesalers/distributors throughout the United States.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.