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
Reported: November 27, 2019 Initiated: November 4, 2019 #D-0518-2020
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
Reason for Recall
Presence of foreign substance: Brown/black particles found during stability testing.
Details
- Recalling Firm
- Teva Pharmaceuticals USA, Inc.
- Units Affected
- 3,623 bottles
- Distribution
- Product was distributed to wholesalers/distributors throughout the United States.
- Location
- North Wales, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Teva Pharmaceuticals USA, Inc.. Units affected: 3,623 bottles.
Why was this product recalled? ▼
Presence of foreign substance: Brown/black particles found during stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 27, 2019. Severity: Moderate. Recall number: D-0518-2020.
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