Recalls / Class II
Class IID-1513-2019
Product
Temozolomide Capsules, 250 mg, 5-count bottle, Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-542-07.
- 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 #: A062228, A062227, A062226, A062295, A062294, Exp 08/31/2019; A069325, A069323, Exp 05/31/2020; A072015, Exp 10/31/2020; A076611, A076609, A076608, A076607, 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
- 11472 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-1513-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.