Teva Recalls Clonazepam Tablets Due to Failed Stability Specifications
Teva Pharmaceuticals is recalling 1,373 cartons of Clonazepam Orally Disintegrating Tablets because routine stability testing revealed out-of-specification water content.
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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures.
Plain-English summary
Teva Pharmaceuticals USA is recalling 1,373 60-count cartons of Clonazepam Orally Disintegrating Tablets USP, 2 mg. (NDC 0555-0098-96). The affected product is identified by Lot # 34033752A and an expiration date of 1/2020.
The recall was initiated because routine stability testing resulted in an out-of-specification test result for water content. This failure indicates that the product did not meet the required stability specifications.
The product was distributed throughout the United States to various distributors, who may have further distributed the product. Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be returned to the pharmacy or distributor for disposal or credit.
The recalled product
- Product
- Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only. Teva Pharmaceuticals USA, INC. North Whales, PA 19454. NDC 0555-0098-96
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
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 # 34033752A
- EXP 1/2020
Distribution
Distribution scope not specified by the agency.
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