D-0518-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 27, 2019
- Initiation Date
- November 4, 2019
- Termination Date
- November 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,623 bottles
Product Description
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 Pattern
Product was distributed to wholesalers/distributors throughout the United States.
Code Information
Lot #: CBFCN, CBHFG, Exp 05/2020