Agency classClass IIOur severity:Severe FDA (Drugs)·D-0179-2015·Announced 2014-11-12

FDA Recalls Calcium Chloride Injectable Due to Sterility Assurance Concerns

Oregon Compounding Centers is recalling specific lots of Calcium Chloride Injectable 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 recall is classified as FDA Class II, which corresponds to a Severe severity score (4) under the rubric, as it involves a potential risk to sterility assurance for injectable products.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Calcium Chloride (Compound), 100 mg/mL, Injectable, 10 mL glass vials manufactured by Oregon Compounding Centers, Inc. dba Creative Compounds. The recall is limited to Lot # 20140815@47 with a discard date of 1/28/2015. The total quantity involved is 580 mL.

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 the sterility of the compounded products. This issue affects all lots of sterile products compounded by the pharmacy that have not expired.

The affected products were distributed in Oregon and Washington. Patients and healthcare providers should discontinue use of the recalled lot and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product: CALCIUM CHLORIDE (COMPOUND), 100 mg/mL, Injectable, 10 mL glass vial, 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 (2)

Lot #: 20140815@47
discard date: 1/28/2015

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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