Why it was recalled
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Product description
Temozolomide Capsules, 140 mg, packaged in a) 5-count bottle (NDC 67877-540-07), b) 14-count bottle (NDC 67877-540-14), 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) A063581, A063462, A063460, Exp 09/30/2019; A063582, Exp 10/31/2019; A069129, Exp 05/31/2020; A071801, Exp 09/30/2020; b) A063639, A063624, A063609, Exp 09/30/2019; A063657, Exp 10/31/2019; A069366, Exp 05/31/2020; A071817, A071819, A071818, Exp 09/30/2020
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-1511-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 16, 2019
- FDA report date
- Jul 31, 2019
- Quantity
- a) 7380 bottles; b) 10332 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Deva Holding AS - Cerkezkoy Subesi
Original FDA data
Every field from FDA enforcement report D-1511-2019, 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) A063581, A063462, A063460, Exp 09/30/2019; A063582, Exp 10/31/2019; A069129, Exp 05/31/2020; A071801, Exp 09/30/2020; b) A063639, A063624, A063609, Exp 09/30/2019; A063657, Exp 10/31/2019; A069366, Exp 05/31/2020; A071817, A071819, A071818, Exp 09/30/2020
- Report date
- Jul 31, 2019
- Product type
- Drugs
- Recall number
- D-1511-2019
- Classification
- Class II
- Recalling firm
- Deva Holding AS - Cerkezkoy Subesi
- Product quantity
- a) 7380 bottles; b) 10332 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, 140 mg, packaged in a) 5-count bottle (NDC 67877-540-07), b) 14-count bottle (NDC 67877-540-14), 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