FDAFDA · Food and drugs·Recall number D-1510-2019
Temozolomide Capsules, 100 mg, packaged in a) 5-count bottle (NDC 67877-539-07), b) 14-count bottle (NDC 67877-539-14), 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) A061783, A061782, A061781, Exp 07/31/2019; A069128, Exp 05/31/2020; A071923, Exp 09/30/20; b) A061874, A061861, A061896, Exp 07/31/2019; A069326, Exp 05/31/2020; A071924, A071977, A071925, Exp 09/30/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- Turkey
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