Reported Jul 31, 2019 · Terminated
Temozolomide Capsules, 20 mg, packaged in a) 5-count bottle (NDC 67877-538-07), b) 14-count bottle (NDC 67877-538-14),…
Deva Holding AS - Cerkezkoy Subesi
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Deva Holding AS - Cerkezkoy Subesi · Organize Fatih Bulvar Fatih Bulvar 32 Cerkezkoy · Cerkezkoy, N/A · N/A
Is this the product you have?
- Temozolomide Capsules, 20 mg, packaged in a) 5-count bottle (NDC 67877-538-07), b) 14-count bottle (NDC 67877-538-14), Rx only
- Manufactured byDeva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303
- Distributed byAscend Laboratories, LLC, Parsippany, NJ 07054
- Lot codes and dates
Lot #: a) A061688A061687A061685Exp 07/31/2019A068994Exp 04/30/2020A071853Exp 09/30/20b) A061794A061833A061822Exp 07/31/2019A069115Exp 04/30/2020A071855A071854Exp 09/30/2020
- Amount recalled
- a) 11376 bottles; b) 13620 bottles
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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