Reported Nov 27, 2019 · Terminated

Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL (3.4 fl. oz.) bottle, Rx only, Manufactured for:…

Teva Pharmaceuticals USA, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Teva Pharmaceuticals USA, Inc. · 1090 Horsham Rd · North Wales, PA · 19454-1505

Is this the product you have?

  • Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL (3.4 fl. oz.) bottle, Rx only
  • Manufactured forActavis Laboratories FL. Inc., Fort Lauderdale, FL 33314
  • Distributed byActavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-2579-20
Lot codes and dates
  • Lot #: CBFCN, CBHFG, Exp 05/2020
Amount recalled
3,623 bottles

Why it was recalled

Presence of foreign substance: Brown/black particles found during stability testing.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Nov 17, 2020 · Data as of Sep 19, 7:59 PM UTC

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