FDA-Drug2019-11-27Class II
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
Teva Pharmaceuticals USA, Inc.
Hazard
Presence of foreign substance: Brown/black particles found during stability testing.
Sold states
Product was distributed to wholesalers/distributors throughout the United States.
Affected count
3,623 bottles
Manufactured in
1090 Horsham Rd, N/A, North Wales, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0518-2020Don't want to check this manually?
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