Drug 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
D-0518-2020
Product summary
- Event
- Event 84242
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,623 bottles
- Official record key
drug-enforcement:D-0518-2020
Official wording
Reason: Presence of foreign substance: Brown/black particles found during stability testing.
Code information: Lot #: CBFCN, CBHFG, Exp 05/2020
Distribution pattern: Product was distributed to wholesalers/distributors throughout the United States.
Derived failure modes
-
Foreign material or chemical contamination
foreign substance