Temozolomide Capsules, 180 mg, packaged in a) 5-count bottle (NDC 67877-541-07), b) 14-count bottle (NDC 67877-541-14), 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, 180 mg, distributed nationwide in the USA due to current Good Manufacturing Practice (CGMP) deviations. The product was manufactured under conditions that did not prevent possible cross contamination with beta lactam products, which are a class of antibiotics that can cause serious allergic reactions in susceptible individuals. The recall involves 5,052 bottles in 5-count packaging (NDC 67877-541-07) and 3,816 bottles in 14-count packaging (NDC 67877-541-14), across multiple lot numbers with expiration dates ranging from July 2019 through April 2021.
The affected lot numbers for the 5-count bottles are A061858, A061857, A061856, A061860, A061859, A069401, A069402, A071978, A076736, and A076735. The affected lot numbers for the 14-count bottles are A062031, A062015, A062014, A062050, A062038, A069521, A069470, A071979, A072014, A072013, A076739, A076738, and A076737. The source document does not specify a remedy or instructions for affected consumers.
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) 5052 bottles; b) 3816 bottles Lot/code info: Lot #: a) A061858, A061857, A061856, A061860, A061859, Exp 07/31/2019; A069401, A069402, Exp 05/31/2020; A071978, Exp 09/30/2020; A076736, A076735, Exp 04/30/2021; b) A062031. A062015, A062014, A062050, A062038, Exp 07/31/2019; A069521, A069470, Exp 05/31/2020; A071979, A072014, A072013, Exp 09/30/2020; A076739, A076738, A076737, Exp 04/30/2021
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.