Agency classClass IIOur severity:Severe FDA (Drugs)·D-0177-2015·Announced 2014-11-12

FDA Recalls AVASTIN Syringes Due to Sterility Assurance Concerns

Oregon Compounding Centers is recalling AVASTIN syringes because quality control issues observed during an FDA inspection present a potential risk to sterility assurance.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or high-risk conditions like sterility assurance failures in injectable drugs are categorized as Severe.

Plain-English summary

Oregon Compounding Centers, Inc. dba Creative Compounds is recalling 5,483 syringes of AVASTIN, 1.25mg/0.5mL, injectable. The product is distributed in Oregon and Washington.

The recall is due to a lack of sterility assurance. The FDA identified concerns associated with quality control procedures during a recent inspection that present a potential risk to the sterility of the compounded products. The recall includes all lots of sterile products compounded by the pharmacy that are not expired.

Consumers and healthcare providers should check their inventory for the specific lot numbers listed in the recall notice and discontinue use of the affected products.

The recalled product

Product: AVASTIN, 1.25mg/0.5mL, injectable, 0.05 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070.
Manufacturer: Oregon Compounding Centers, Inc. dba Creative Compounds
Category: Drug — Injectable
Hazard: sterility-assurance
infection-risk

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 #: 20140715@13
discard date: 11/3/2014
Lot #: 20140716@25
discard date: 10/14/2014
Lot #: 20140717@7
discard date: 10/15/2014
Lot #: 20140724@14
discard date: 10/22/2014
Lot #: 20140724@15
Lot #: 20140729@11
discard date: 10/27/2014
Lot #: 20140801@17
discard date: 10/30/2014
Lot #: 20140805@1
Lot #: 20140807@13
discard date: 11/5/2014
Lot #: 20140811@30
discard date: 11/9/2014
Lot #: 20140813@10
discard date: 11/11/2014

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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Same hazard · sterility assurance