Drug recall D-0518-2020
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.
Lots and codes
Lot #: CBFCN, CBHFG, Exp 05/2020
Recall details
- Recalling firm
- Teva Pharmaceuticals USA, Inc., North Wales, PA
- Quantity
- 3,623 bottles
- Distribution
- Product was distributed to wholesalers/distributors throughout the United States.
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 4, 2019
- Terminated
- November 17, 2020
Related products
- Valganciclovir hydrochloride for Oral – drug information
- NDC 0591-2579 Valganciclovir hydrochloride for Oral · Valganciclovir Hydrochloride 50 mg/mL · Actavis Pharma, Inc.