Why it was recalled
Presence of foreign substance: Brown/black particles found during stability testing.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: CBFCN, CBHFG, Exp 05/2020
Where it was sold
Product was distributed to wholesalers/distributors throughout the United States.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0518-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 4, 2019
- FDA report date
- Nov 27, 2019
- Quantity
- 3,623 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
Original FDA data
Every field from FDA enforcement report D-0518-2020, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 84242
- Address
- 1090 Horsham Rd
- Code information
- Lot #: CBFCN, CBHFG, Exp 05/2020
- Postal code
- 19454-1505
- Report date
- Nov 27, 2019
- Product type
- Drugs
- Recall number
- D-0518-2020
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
- Product quantity
- 3,623 bottles
- Termination date
- Nov 17, 2020
- Reason for recall
- Presence of foreign substance: Brown/black particles found during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Product was distributed to wholesalers/distributors throughout the United States.
- Recall initiation date
- Nov 4, 2019
- Initial firm notification
- Letter
- Center classification date
- Nov 21, 2019