Temozolomide Capsules, 20 mg, packaged in a) 5-count bottle (NDC 67877-538-07), b) 14-count bottle (NDC 67877-538-14), 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, 20 mg, in two package sizes distributed nationwide in the USA. The recall affects 11,376 bottles of the 5-count size (NDC 67877-538-07) and 13,620 bottles of the 14-count size (NDC 67877-538-14). Multiple lot numbers are involved with expiration dates ranging from July 2019 through September 2020.
The recall was initiated due to current Good Manufacturing Practice (CGMP) deviations during manufacturing that did not prevent possible cross contamination with beta lactam products, which could pose a risk to patients with beta lactam allergies. The source document does not specify a remedy or recommended action 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) 11376 bottles; b) 13620 bottles Lot/code info: Lot #: a) A061688, A061687, A061685, Exp 07/31/2019; A068994, Exp 04/30/2020; A071853, Exp 09/30/20; b) A061794, A061833, A061822, Exp 07/31/2019; A069115, Exp 04/30/2020; A071855, A071854, Exp 09/30/2020
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.