Temozolomide Capsules recalled over manufacturing violations
- Recall date
- July 16, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Deva Holding AS - Cerkezkoy Subesi recalls Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 67877-537-07), b) 14-count bottle (NDC 67877-537-14), R…
- Recall number
- D-1508-2019
- FDA classification
- Class II
- Brand / firm
- Deva Holding AS - Cerkezkoy Subesi
- Sold / distributed
- Nationwide in the USA.
Why it was recalled
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 67877-537-07), b) 14-count bottle (NDC 67877-537-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
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