Agency classClass IOur severity:Critical FDA (Drugs)·D-0230-2015·Announced 2014-11-05

FDA Recalls Calcium Glucosate Injection Due to Microbial Contamination

Specialty Compounding, LLC is recalling Calcium Gluconate 2 gm in 100 mL Sodium Chloride 0.9% for Injection due to non-sterility and microbial contamination.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source text explicitly identifies the agency classification as 'Class I', which corresponds to the 'Critical' severity level (Score 5) in the rubric.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Calcium Glucosate 2 gm (PF) Preservative Free in 100 mL Sodium Chloride 0.9% for Injection, Rx Only. The product is manufactured by Specialty Compounding, LLC, located in Cedar Park, Texas.

The recall was initiated because the product was found to be non-sterile, indicating microbial contamination. This specific lot is identified by Lot # 07092013M16 with an expiration date of 09/13. The distribution pattern for this product is listed as nationwide.

Consumers and healthcare providers should stop using the affected product immediately. The FDA classifies this as a Class I recall, which is the most serious type of recall, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.

The recalled product

Product: CALCIUM GLUCONATE 2 gm (PF) PRESERVATIVE FREE in 100 mL Sodium Chloride 0.9% for Injection, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613
Manufacturer: Specialty Compounding, LLC
Category: Drug — Injectable Medication
Hazard: microbial-contamination
non-sterility

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 #: 07092013M16
Exp 09/13

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Specialty Compounding, LLC 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 2 products in this recall →

Same manufacturer · Specialty Compounding, LLC

See all →

Severe
Specialty Compounding Recalls All Prescription Products Due to Sterility Concerns
FDA (Drugs) · 2014-11-05

Same hazard · microbial contamination