FDAFDA · Food and drugs·Recall number D-1512-2019
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.
Published July 31, 2019 · Recall initiated: July 16, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Brand
- TEMOZOLOMIDE
- Manufacturer
- Deva Holding AS - Cerkezkoy Subesi
- Distributor
- Nationwide in the USA.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- Turkey
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