Teva Recalls Valacyclovir Tablets Due to Potential Foreign Tablet Fragments
Teva Pharmaceuticals USA is recalling Valacyclovir Hydrochloride 1 g tablets because bottles may contain fragments of Pravastatin tablets.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with significant injury or property damage reports, or structural defects, are Severe. While no specific injuries are reported in the text, the presence of a different medication (Pravastatin) in a Valacyclovir bottle represents a significant medication error risk that aligns with the 'Severe' criteria for significant potential harm or structural defect in packaging integrity.
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling 7,020 bottles of Valacyclovir Hydrochloride Tablets, 1 g, 30 count, NDC #0093-7259-56. The product is prescription-only and was manufactured in Israel by Teva Pharmaceuticals Ind., LTD, Jerusalem, Israel, for Teva Pharmaceuticals USA, Sellersville, PA.
The recall is being issued due to the presence of foreign tablets or capsules, specifically the potential presence of Pravastatin tablet fragments in bottles of Valacyclovir 1 gm Tablets. The affected lot is W22042. The product was distributed nationwide.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for guidance on replacement or return.
The recalled product
- Product
- Valacyclovir Hydrochloride Tablets, 1 g, 30 count bottle, Rx only manufactured in Israel by Teva Pharmaceuticals Ind., LTD, Jerusalem, Israel, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA. NDC #0093-7259-56
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 7,020
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 (1)
- Lot W22042
Distribution
Distributed nationwide across the United States.
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