The Recall Desk
HighFDA (Drugs)·D-1512-2019·Announced 2019-07-31

FDA Recalls Temozolomide Capsules Due to Cross-Contamination Risk

Deva Holding AS is recalling Temozolomide Capsules because manufacturing deviations allowed for possible cross-contamination with beta-lactam products.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential cross-contamination with beta-lactams, which poses a significant risk of allergic reactions in sensitive patients, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Temozolomide Capsules, 180 mg, manufactured by Deva Holding AS and distributed by Ascend Laboratories, LLC. The recall affects 5-count and 14-count bottles of the prescription medication, which are distributed nationwide in the USA.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the product was manufactured in a manner that did not prevent possible cross-contamination with beta-lactam products. Temozolomide is an alkylating drug used for the treatment of certain cancers.

Patients and healthcare providers should stop using the affected lots and contact their healthcare provider for guidance on alternative treatment options. The specific lot numbers and expiration dates are listed in the official FDA recall notice D-1512-2019.

The recalled product

Product
TEMOZOLOMIDE (TEMOZOLOMIDE)
Brand
TEMOZOLOMIDE
Manufacturer
Deva Holding AS - Cerkezkoy Subesi
Category
Drug — Antineoplastic
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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
  • A069521
  • A069470

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Deva Holding AS - Cerkezkoy Subesi under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same brand · TEMOZOLOMIDE

Same manufacturer · Deva Holding AS - Cerkezkoy Subesi

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Same hazard · cross contamination

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