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 for recall: Presence of foreign substance: Brown/black particles found during stability testing.
Recall initiated: 20191104
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated