The Recall Desk
SevereFDA (Drugs)·D-0222-2015·Announced 2014-11-12

Sodium Chloride Inhalation Solution Recalled for Sterility Assurance Concerns

Oregon Compounding Centers is recalling Sodium Chloride Inhalation 7% solution due to quality control issues affecting sterility assurance.

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. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility assurance failures) are categorized as Severe (Score 4).

Plain-English summary

Oregon Compounding Centers, Inc. dba Creative Compounds is recalling Sodium Chloride Inhalation, 7%, Solution for inhalation, 3 mL plastic vial. 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. The recall includes all lots of sterile products compounded by the pharmacy that are not expired. The specific lot identified in the recall notice is Lot # 20140916@23 with a discard date of 10/31/2014. The product was distributed in Oregon and Washington.

Consumers and healthcare providers should check their inventory for this product and discontinue use if the lot number matches the recalled item. 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
SODIUM CHLORIDE INHALATION, 7%, Solution for inhalation, 3 mL plastic vial, 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@23
  • discard date: 10/31/2014

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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