Agency classClass IIOur severity:Severe FDA (Drugs)·D-0182-2015·Announced 2014-11-12

FDA Recalls Chorionic Gonadotropin Vials Due to Sterility Assurance Concerns

Oregon Compounding Centers is recalling 117 vials of Chorionic Gonadotropin due to quality control issues affecting 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 agency classification is FDA Class II, and the hazard involves a lack of sterility assurance in a sterile injectable product, which poses a significant risk of serious injury.

Plain-English summary

Oregon Compounding Centers, Inc. dba Creative Compounds is recalling 117 vials of Chorionic Gonadotropin, 5000 Units, sterile powder for reconstitution. The affected lots are 20140909@5 (discard date 3/8/2015) and 20140728@57 (discard date 1/14/2015). The product was distributed in Oregon and Washington.

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

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product: CHORIONIC GONADOTROPIN, 5000 Units, sterile powder for reconstitution, glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Manufacturer: Oregon Compounding Centers, Inc. dba Creative Compounds
Category: Drug — Compounded Sterile Product
Hazard: sterility-assurance
infection
Affected units: 117

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 (4)

Lot #: 20140909@5
discard date: 3/8/2015
Lot #: 20140728@57
discard date: 1/14/2015.

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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