Recalls / Class II
Class IID-1512-2019
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 name
- Temozolomide
- Generic name
- Temozolomide
- Active ingredient
- Temozolomide
- Route
- Oral
- NDCs
- 67877-537, 67877-538, 67877-539, 67877-540, 67877-541, 67877-542
- FDA application
- ANDA207658
- Affected lot / code info
- 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
Why it was recalled
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Recalling firm
- Firm
- Deva Holding AS - Cerkezkoy Subesi
- Manufacturer
- Ascend Laboratories, LLC
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- Organize Fatih Bulvar Fatih Bulvar 32 Cerkezkoy, N/A, Cerkezkoy, N/A N/A, Turkey
Distribution
- Quantity
- a) 5052 bottles; b) 3816 bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2019-07-16
- FDA classified
- 2019-07-23
- Posted by FDA
- 2019-07-31
- Terminated
- 2022-01-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1512-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.