Teva Recalls Clozapine Tablets Due to Microbial Contamination
Teva Pharmaceuticals is recalling specific lots of Clozapine Tablets USP, 25 mg, due to microbial contamination of non-sterile products.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves microbial contamination, which poses a risk of harm, but no illnesses or injuries have been reported in the source text.
Plain-English summary
Teva Pharmaceuticals USA is recalling specific lots of Clozapine Tablets USP, 25 mg, due to microbial contamination of non-sterile products. The affected products include 100-count bottles (NDC 0093-4359-01), 500-count bottles (NDC 0093-4359-05), 100 Unit Dose Blisters per carton (NDC 0093-4359-93), and Individual Blister Packs (NDC 0093-4359-19). The recall is classified as Class II by the FDA.
The affected lots are Lot # 07C160 for the 100 and 500-count bottles, and Lot # 07C160A for the Unit Dose Blisters and Individual Blister Packs. All affected products have an expiration date of 03/18. The products were distributed nationwide.
Consumers and healthcare providers should stop using the affected lots and contact their pharmacist or Teva Pharmaceuticals for further instructions. This recall is precautionary, and no illnesses or injuries have been reported in the source text.
The recalled product
- Product
- Clozapine Tablets USP, 25 mg, 100-count bottle (NDC 0093-4359-01), 500- count bottle (NDC 0093-4359-05), 100 Unit Dose Blisters per carton (NDC 0093-4359-93), Individual Blister Pack (NDC 0093-4359-19), Rx Only, Manufactured By: Teva Pharmaceutical Industries Ltd., Jerusalem…
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Antipsychotic
- 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)
- 100 (NDC 0093-4359-01) and 500 count bottles (NDC 0093-4359-05)- Lot # 07C160
- Exp. 03/18
Distribution
Distributed nationwide across the United States.
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