Reported Jul 31, 2019 · Terminated
Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 67877-537-07), b) 14-count bottle (NDC 67877-537-14),…
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, 5 mg, packaged in a) 5-count bottle (NDC 67877-537-07), b) 14-count bottle (NDC 67877-537-14), Rx only
- Manufactured byDeva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303
- Distributed byAscend Laboratories, LLC, Parsippany, NJ 07054
- Lot codes and dates
6 of 6 products
Products covered by this recall # Product as published 1 A062238, A062118, A062115, A062112, A062100, Exp 08/31/2019 2 A068946, Exp 04/30/2020 3 A071733, Exp 09/30/2020 4 A062194, A062181, A62275, A062218, Exp 08/31/2019 5 A069154, Exp 04/30/2020 6 A071734, A071783, A071735, Exp 09/30/2020 - Amount recalled
- a) 5736 bottles; b) 8460 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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