Teva Pharmaceuticals USA, Inc. recalls Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL (3.4 fl. oz.) bottle, Rx only, Manufactured for: Actav…
- Recall date
- November 4, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0518-2020
- FDA classification
- Class II
- Brand / firm
- Teva Pharmaceuticals USA, Inc.
- Sold / distributed
- Product was distributed to wholesalers/distributors throughout the United States.
Why it was recalled
Presence of foreign substance: Brown/black particles found during stability testing.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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