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.
Check against the official notice below — it lists the full affected range.
Deva Holding AS is recalling Temozolomide Capsules, 5 mg, in both 5-count and 14-count bottles distributed nationwide in the USA. The recall affects multiple lot numbers with expiration dates ranging from August 2019 to September 2020. The capsules were manufactured under conditions that did not prevent possible cross contamination with beta lactam products, which violates current good manufacturing practices (CGMP).
The affected products have the following National Drug Codes: NDC 67877-537-07 for the 5-count bottles (5,736 bottles recalled) and NDC 67877-537-14 for the 14-count bottles (8,460 bottles recalled). The source document does not specify what actions affected consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Reason for recall: CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. Distribution: Nationwide in the USA. Quantity: a) 5736 bottles; b) 8460 bottles Lot/code info: Lot #: a) A062238, A062118, A062115, A062112, A062100, Exp 08/31/2019; A068946, Exp 04/30/2020; A071733, Exp 09/30/2020; b) A062194, A062181, A62275, A062218, Exp 08/31/2019; A069154, Exp 04/30/2020; A071734, A071783, A071735, Exp 09/30/2020
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.