Temozolomide Capsules Recalled for Potential Cross-Contamination with Beta-Lactam Products
Deva Holding AS is recalling Temozolomide Capsules due to manufacturing deviations that allowed possible cross-contamination with beta-lactam 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 a risk-of-harm product (potential cross-contamination with beta-lactams) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria.
Plain-English summary
Deva Holding AS is recalling Temozolomide Capsules, 100 mg, in 5-count and 14-count bottles. The recall was initiated because the product was manufactured under conditions that did not prevent possible cross-contamination with beta-lactam products.
The affected lots include A061783, A061782, A061781, A069128, A071923, A061874, A061861, A061896, A069326, A071924, A071977, and A071925. These products were distributed nationwide in the United States by Ascend Laboratories, LLC. The total quantity recalled is 13,752 bottles of the 5-count size and 15,696 bottles of the 14-count size.
Patients and healthcare providers should stop using the recalled Temozolomide Capsules and contact their healthcare provider for further instructions. The FDA has classified this recall as 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
- TEMOZOLOMIDE (TEMOZOLOMIDE)
- Brand
- TEMOZOLOMIDE
- Manufacturer
- Deva Holding AS - Cerkezkoy Subesi
- Category
- Drug — Prescription Drug
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 (16)
- Lot #: a) A061783
- A061782
- A061781
- Exp 07/31/2019
- A069128
- Exp 05/31/2020
- A071923
- Exp 09/30/20
- b) A061874
- A061861
- A061896
- A069326
- A071924
- A071977
- A071925
- Exp 09/30/2020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Deva Holding AS - Cerkezkoy Subesi under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same brand · TEMOZOLOMIDE
- HighTemozolomide capsules recalled after failing impurities and degradation specifications
FDA (Drugs) · 2026-03-11
- ModerateFDA Recalls Temozolomide Capsules Due to Cross-Contamination Risk
FDA (Drugs) · 2019-07-31
- HighFDA Recalls Temozolomide Capsules Due to Cross-Contamination Risk
FDA (Drugs) · 2019-07-31
- ModerateTemozolomide Capsules Recalled for Potential Cross-Contamination with Beta-Lactam Products
FDA (Drugs) · 2019-07-31
- HighTemozolomide Capsules Recalled for Potential Cross-Contamination with Beta-Lactam Products
FDA (Drugs) · 2019-07-31
Same manufacturer · Deva Holding AS - Cerkezkoy Subesi
See all →- HighTemozolomide Capsules Recalled for Potential Cross-Contamination with Beta-Lactam Products
FDA (Drugs) · 2019-07-31
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