Teva Recalls Divalproex Sodium Tablets Due to Failed Specifications
Teva North America is recalling Divalproex Sodium Delayed-release Tablets because they failed tablet specifications. The recall covers 14,370 units distributed nationwide and in Puerto Rico.
What this means for you
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 III, which indicates a low risk of adverse health consequences, and the source text does not report any specific injuries or illnesses.
Plain-English summary
Teva North America is recalling Divalproex Sodium Delayed-release Tablets USP, 250 mg, 100 count bottles (NDC 0093-7440-01). The recall was initiated because the product failed tablet/capsule specifications. The affected lot is 02D163 with an expiration date of 9/2017.
The recall involves 14,370 units that were distributed nationwide and in Puerto Rico. The product was manufactured in Israel by TEVA PHARMACEUTICALS IND. LTD. and manufactured for TEVA PHARMACEUTICALS USA, INC.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment.
The recalled product
- Product
- Divalproex Sodium Delayed-release Tablets USP, RX, 250 mg, 100 count bottles, Manufactured in Israel by: TEVA PHARMACEUTICALS IND. LTD. Jerusalem, 9777402, Israel, Manufactured for: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454, NDC 0093-7440-01.
- Manufacturer
- Teva North America
- Category
- Drug — Anticonvulsant
- Hazard
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 (2)
- Lot #: 02D163
- Exp. 9/2017
Distribution
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