The Recall Desk
SevereFDA (Drugs)·D-0178-2015·Announced 2014-11-12

FDA Recalls Bevacizumab/Dexamethasone Injectable Due to Sterility Assurance Concerns

Oregon Compounding Centers is recalling Bevacizumab/Dexamethasone injectable syringes due to quality control issues affecting sterility assurance identified during an FDA inspection.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a lack of sterility assurance in an injectable product, which poses a significant risk of infection or serious injury, meeting the criteria for a Severe rating.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Bevacizumab/Dexamethasone, 1.25/0.5 mL, Injectable, 0.05 mL plastic syringe, manufactured by Oregon Compounding Centers, Inc. dba Creative Compounds. The recall covers all lots of sterile products compounded by the pharmacy that are not expired. The specific lot number identified in the recall notice is 20140916@3, with a discard date of 12/15/2014. The product was distributed in Oregon and Washington.

The recall was initiated due to a lack of sterility assurance. During a recent FDA inspection, quality control procedures were observed that present a potential risk to sterility assurance. The agency has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Patients who have received this medication should contact their healthcare provider for guidance. The recalling firm is responsible for notifying customers and ensuring the product is removed from distribution.

The recalled product

Product
BEVACIZUMAB/DEXAMETHASONE, 1.25/0.5 mL, Injectable, 0.05 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070.

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 (2)

  • Lot #: 20140916@3
  • discard date: 12/15/2014.

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 56 recalled by Oregon Compounding Centers, Inc. dba Creative Compounds 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 56 products in this recall →

Same manufacturer · Oregon Compounding Centers, Inc. dba Creative Compounds

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