Temozolomide Capsules 180mg (Deva Holding) – Cross-Contamination Risk (2019)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Temozolomide Capsules, 180 mg, packaged in a) 5-count bottle (NDC 67877-541-07), b) 14-count bottle (NDC 67877-541-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
Brand
Deva Holding AS - Cerkezkoy Subesi
Lot Codes / Batch Numbers
Lot #: a) A061858, A061857, A061856, A061860, A061859, Exp 07/31/2019, A069401, A069402, Exp 05/31/2020, A071978, Exp 09/30/2020, A076736, A076735, Exp 04/30/2021, b) A062031. A062015, A062014, A062050, A062038, Exp 07/31/2019, A069521, A069470, Exp 05/31/2020, A071979, A072014, A072013, Exp 09/30/2020, A076739, A076738, A076737, Exp 04/30/2021
Products Sold
Lot #: a) A061858, A061857, A061856, A061860, A061859, Exp 07/31/2019; A069401, A069402, Exp 05/31/2020; A071978, Exp 09/30/2020; A076736, A076735, Exp 04/30/2021; b) A062031. A062015, A062014, A062050, A062038, Exp 07/31/2019; A069521, A069470, Exp 05/31/2020; A071979, A072014, A072013, Exp 09/30/2020; A076739, A076738, A076737, Exp 04/30/2021
Deva Holding AS - Cerkezkoy Subesi is recalling Temozolomide Capsules, 180 mg, packaged in a) 5-count bottle (NDC 67877-541-07), b) 14-count bottle due to CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026