The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1508-2019·Announced 2019-07-31

FDA Recalls Temozolomide Capsules Due to Cross-Contamination Risk

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

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which is a reasonable probability of temporary or medically reversible adverse health consequences. The hazard is a theoretical cross-contamination risk without reported illnesses, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Temozolomide Capsules, 5 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 United States.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturing process did not prevent possible cross-contamination with beta-lactam products. Temozolomide is an oral prescription drug used for cancer treatment.

Patients and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the official recall notice. If you have these products, you should stop using them and contact your healthcare provider or pharmacist for guidance on replacement or disposal.

The recalled product

Product
TEMOZOLOMIDE (TEMOZOLOMIDE)
Brand
TEMOZOLOMIDE
Manufacturer
Deva Holding AS - Cerkezkoy Subesi
Category
Drug — Prescription Medication
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 (18)

  • 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
  • A069154
  • A071734
  • A071783
  • A071735

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 →

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