FDA recall D-0518-2020

Teva Pharmaceuticals USA, Inc. · Class II · drug

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.

Distribution

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

Key facts

Status: Terminated
Initiation date: 2019-11-04
Report date: 2019-11-27
Termination date: 2020-11-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: North Wales, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0518-2020