Teva Recalls Clozapine Tablets Due to Potential Broken Tablets
Teva Pharmaceuticals USA is recalling 3,870 bottles of Clozapine Tablets USP, 100 mg, due to failed specifications and potential broken tablets.
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 II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Teva Pharmaceuticals USA is voluntarily recalling 3,870 bottles of Clozapine Tablets USP, 100 mg, 500 count bottles. The recall involves Lot # 39C192 with an expiration date of 06/2019. The product is manufactured in Israel by TEVA PHARMACEUTICALS IND, LTD and distributed nationwide.
The recall was initiated because the tablets failed to meet specifications, with a potential presence of broken tablets. The agency has classified this recall as Class II.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for further instructions or a replacement.
The recalled product
- Product
- Clozapine Tablets USP, 100 mg, 500 count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICALS IND, LTD, Jerusalem Israel, Manufactured For: TEVA PHARMACEUTICALS USA, North Wales, PA, NDC 00093-7772-05
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 3,870
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 # 39C192
- exp 06/2019
Distribution
Distributed nationwide across the United States.
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