Temozolomide Capsules, 100 mg, packaged in a) 5-count bottle (NDC 67877-539-07), b) 14-count bottle (NDC 67877-539-14), 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 100 mg in two package sizes distributed nationwide. The 5-count bottles (NDC 67877-539-07) and 14-count bottles (NDC 67877-539-14) are affected across multiple lot numbers with expiration dates ranging from July 2019 through September 2020. A total of 13,752 five-count bottles and 15,696 fourteen-count bottles are involved in this recall.
The recall was issued because the product was manufactured under conditions that did not prevent possible cross contamination with beta lactam products, which represents a deviation from good manufacturing practices (CGMP). The source document does not specify a remedy or recommended action for consumers who may have obtained affected product.
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) 13752 bottles; b) 15696 bottles Lot/code info: Lot #: a) A061783, A061782, A061781, Exp 07/31/2019; A069128, Exp 05/31/2020; A071923, Exp 09/30/20; b) A061874, A061861, A061896, Exp 07/31/2019; A069326, Exp 05/31/2020; A071924, A071977, A071925, Exp 09/30/2020
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.