The Recall Desk
HighFDA (Drugs)·D-1513-2019·Announced 2019-07-31

Temozolomide Capsules Recalled for Potential Cross-Contamination with Beta-Lactam Products

Deva Holding AS is recalling Temozolomide Capsules due to manufacturing deviations that allowed 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. The hazard involves potential cross-contamination with beta-lactam antibiotics, which poses a significant risk of allergic reaction (anaphylaxis) to sensitive individuals, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Deva Holding AS is recalling 11,472 bottles of Temozolomide Capsules, 250 mg, 5-count bottles. The product is distributed nationwide in the USA by Ascend Laboratories, LLC. The recall involves specific lot numbers with expiration dates ranging from August 2019 to April 2021.

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. Beta-lactams are a class of antibiotics to which some patients may have severe allergic reactions.

Patients and healthcare providers should check their inventory for the affected lot numbers listed in the recall notice. If the product is found, it should be returned to the distributor or manufacturer for credit. Patients should consult their healthcare provider regarding alternative treatment options if they have received this medication.

The recalled product

Product
TEMOZOLOMIDE (TEMOZOLOMIDE)
Brand
TEMOZOLOMIDE
Manufacturer
Deva Holding AS - Cerkezkoy Subesi
Category
Drug — Antineoplastic
Hazard
Affected units
11,472

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 (16)

  • Lot #: A062228
  • A062227
  • A062226
  • A062295
  • A062294
  • Exp 08/31/2019
  • A069325
  • A069323
  • Exp 05/31/2020
  • A072015
  • Exp 10/31/2020
  • A076611
  • A076609
  • A076608
  • A076607
  • Exp 04/30/2021

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

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Same hazard · cross contamination

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