RecallDepth
Class II Terminated

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

This recall has been terminated (originally issued November 27, 2019).

Company
Teva Pharmaceuticals Usa, Inc.
Recall Initiated
November 4, 2019
Posted
November 27, 2019
Recall Number
D-0518-2020
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
3,623 bottles
Firm Location
North Wales, PA, United States
Official Source
View on FDA website ↗

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.

Lot / Code Info

Lot #: CBFCN, CBHFG, Exp 05/2020

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