Recalls / Class II
Class IID-0518-2020
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
- Brand name
- Valganciclovir Hydrochloride For Oral
- Generic name
- Valganciclovir Hydrochloride
- Active ingredient
- Valganciclovir Hydrochloride
- Route
- Oral
- NDC
- 0591-2579
- FDA application
- ANDA205220
- Affected lot / code info
- Lot #: CBFCN, CBHFG, Exp 05/2020
Why it was recalled
Presence of foreign substance: Brown/black particles found during stability testing.
Recalling firm
- Firm
- Teva Pharmaceuticals USA, Inc.
- Manufacturer
- Actavis Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1090 Horsham Rd, N/A, North Wales, Pennsylvania 19454-1505
Distribution
- Quantity
- 3,623 bottles
- Distribution pattern
- Product was distributed to wholesalers/distributors throughout the United States.
Timeline
- Recall initiated
- 2019-11-04
- FDA classified
- 2019-11-21
- Posted by FDA
- 2019-11-27
- Terminated
- 2020-11-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0518-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.