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

Recall Number: D-0518-2020

Firm: Teva Pharmaceuticals USA, Inc.

Classification: Class II

Status: Terminated

Report Date: 20191127

Initiation Date: 20191104

Termination Date: 20201117

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

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