Schering-Plough Recalls Temodar Capsules Due to Degradation Testing Failures
Schering-Plough is recalling 17,169 packages of Temodar (temozolomide) 20 mg capsules due to out-of-specification degradation product testing results.
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, which typically corresponds to a Moderate severity score when no specific hospitalizations or severe injuries are reported in the source text.
Plain-English summary
Schering-Plough Products, LLC is recalling 17,169 packages of Temodar (temozolomide) Capsules, 20 mg per capsule. The affected product is identified by Lot 0NCW005 with an expiration date of 02/2013. The recall is being initiated because of an out-of-specification result in degradation product testing detected during stability monitoring.
The affected capsules were distributed nationwide and in Puerto Rico. The product is a prescription-only medication intended for oral administration and is classified as cytotoxic.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for further instructions. The recall is classified as FDA Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, For Oral Administration, Rx Only, Cytotoxic, NDC: 0085-1519-02, Schering Corporation, Kenilworth, New Jersey, 07033
- Manufacturer
- Schering-Plough Products, LLC
- Category
- Drug — Oncology
- Hazard
- Affected units
- 17,169
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: 0NCW005
- Exp 02/2013
Distribution
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