# FDA recall D-0518-2020

> **Teva Pharmaceuticals USA, Inc.** · Class II · drug recall initiated 2019-11-04.

## 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.

## Distribution

Product was distributed to wholesalers/distributors throughout the United States.

## Key facts

- **Recall number:** D-0518-2020
- **Recalling firm:** Teva Pharmaceuticals USA, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-11-04
- **Report date:** 2019-11-27
- **Termination date:** 2020-11-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North Wales, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0518-2020

## Citation

> AI Analytics. FDA recall D-0518-2020. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/D-0518-2020. Source: US FDA. Licensed CC0.

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