# FDA recall D-1510-2019

> **Deva Holding AS - Cerkezkoy Subesi** · Class II · drug recall initiated 2019-07-16.

## Product

Temozolomide Capsules, 100 mg, packaged in a) 5-count bottle (NDC 67877-539-07), b) 14-count bottle (NDC 67877-539-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.

## Reason for recall

CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-1510-2019
- **Recalling firm:** Deva Holding AS - Cerkezkoy Subesi
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-07-16
- **Report date:** 2019-07-31
- **Termination date:** 2022-01-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cerkezkoy, N/A, Turkey

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1510-2019

## Citation

> AI Analytics. FDA recall D-1510-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1510-2019. Source: US FDA. Licensed CC0.

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