Valganciclovir Hydrochloride for Oral Solution recall
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
Why was Valganciclovir Hydrochloride for Oral Solution recalled?
Presence of foreign substance: Brown/black particles found during stability testing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: CBFCN, CBHFG, Exp 05/2020
- 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
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
- Quantity
- 3,623 bottles
- Distribution
- Product was distributed to wholesalers/distributors throughout the United States.
- Recall date
- November 27, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)