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.
Reported: July 31, 2019 Initiated: July 16, 2019 #D-1508-2019
Product Description
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.
Reason for Recall
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Details
- Recalling Firm
- Deva Holding AS - Cerkezkoy Subesi
- Units Affected
- a) 5736 bottles; b) 8460 bottles
- Distribution
- Nationwide in the USA.
- Location
- Cerkezkoy, N/A
Frequently Asked Questions
What product 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.. Recalled by Deva Holding AS - Cerkezkoy Subesi. Units affected: a) 5736 bottles; b) 8460 bottles.
Why was this product recalled? ▼
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 31, 2019. Severity: Moderate. Recall number: D-1508-2019.
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