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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