FDA Drug recall 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.…
- FDA Drug
- Class II
- terminated
- Published 2019-11-27
On 2019-11-27 the FDA classified a Class II recall of Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL (3.4 fl. oz.) bottle, Rx only, Manufactured for: Actavis Laboratories FL.… by Teva Pharmaceuticals Usa, citing presence of foreign substance: Brown/black particles found during stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0518-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-04 |
| Published | 2019-11-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
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
Presence of foreign substance: Brown/black particles found during stability testing.
Identifiers
| ndc | 0591-2579-20 |
|---|---|
| code_info | Lot #: CBFCN, CBHFG, Exp 05/2020 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0518-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.