Agency classClass IIOur severity:Severe FDA (Drugs)·D-0174-2015·Announced 2014-11-12

FDA Recalls Alprostadil/Lidocaine Vials Due to Sterility Assurance Concerns

Oregon Compounding Centers is recalling Alprostadil/Lidocaine HCL vials due to quality control issues affecting sterility assurance identified during an FDA inspection.

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. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility assurance failures) are classified as Severe (Score 4), particularly when structural or process defects are involved.

Plain-English summary

Oregon Compounding Centers, Inc. dba Creative Compounds is recalling Alprostadil/Lidocaine HCL, 20mcg/5mg/mL, 1.25 mL glass vials. The recall is being conducted due to concerns associated with quality control procedures that present a potential risk to sterility assurance. These concerns were observed during a recent FDA inspection of the pharmacy.

The recall includes all lots of sterile products compounded by the pharmacy that are not expired. The specific product information includes Lot # 20140902@17/1.25 with a discard date of 10/17/2014. The products were distributed in Oregon and Washington.

Consumers and healthcare providers should stop using the recalled products and contact their healthcare provider or the recalling firm for further instructions. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: ALPROSTADIL/LIDOCAINE HCL, 20mcg/5mg/mL, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
Manufacturer: Oregon Compounding Centers, Inc. dba Creative Compounds
Category: Drug — Compounded Sterile Product
Hazard: sterility-assurance
quality-control

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 #: 20140902@17/1.25
discard date: 10/17/2014

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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