Teva Recalls Valganciclovir Hydrochloride Oral Solution Due to Foreign Particles
Teva Pharmaceuticals is recalling specific lots of Valganciclovir Hydrochloride for Oral Solution because brown or black particles were found during stability testing.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation that might cause temporary or medically reversible adverse health consequences. The hazard is the presence of foreign particles, which is a quality issue but does not involve high-risk pathogens or reported serious injuries.
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling 3,623 bottles of Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL. The affected product is identified by NDC 0591-2579-20 and includes lots CBFCN and CBHFG with an expiration date of 05/2020. The recall was initiated because brown or black particles were detected during stability testing.
The product was distributed to wholesalers and distributors throughout the United States. It was manufactured for Actavis Laboratories FL. Inc. and distributed by Actavis Pharma, Inc.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for a replacement or refund. Patients should not discontinue their prescribed medication without consulting their healthcare provider.
The recalled product
- Product
- VALGANCICLOVIR HYDROCHLORIDE FOR ORAL (VALGANCICLOVIR HYDROCHLORIDE)
- Brand
- VALGANCICLOVIR HYDROCHLORIDE FOR ORAL
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Category
- Drug — Antiviral
- Hazard
- Affected units
- 3,623
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: CBFCN
- CBHFG
- Exp 05/2020
Distribution
Distribution scope not specified by the agency.
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