FDAFDA · Food and drugs·Recall number D-0518-2020
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
Published November 27, 2019 · Recall initiated: November 4, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of foreign substance: Brown/black particles found during stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- VALGANCICLOVIR HYDROCHLORIDE FOR ORAL
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Distributor
- Product was distributed to wholesalers/distributors throughout the United States.
- Lot
- Lot #: CBFCN, CBHFG, Exp 05/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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