Why it was recalled
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Product description
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.
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1512-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 16, 2019
- FDA report date
- Jul 31, 2019
- Quantity
- a) 5052 bottles; b) 3816 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Deva Holding AS - Cerkezkoy Subesi
Original FDA data
Every field from FDA enforcement report D-1512-2019, exactly as published.
Show all FDA fields
- City
- Cerkezkoy
- Status
- Terminated
- Country
- Turkey
- Event ID
- 83327
- Address
- Organize Fatih Bulvar Fatih Bulvar 32 Cerkezkoy
- Code information
- 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
- Report date
- Jul 31, 2019
- Product type
- Drugs
- Recall number
- D-1512-2019
- Classification
- Class II
- Recalling firm
- Deva Holding AS - Cerkezkoy Subesi
- Product quantity
- a) 5052 bottles; b) 3816 bottles
- Termination date
- Jan 6, 2022
- Reason for recall
- CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Jul 16, 2019
- Initial firm notification
- Center classification date
- Jul 23, 2019