Zions RX Formulations Recalls Calcium Gluconate Injection Due to Contamination
Zions RX Formulations is recalling 450 vials of Calcium Gluconate 10% for Injection due to a report of 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 agency classification is FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death.
Plain-English summary
Zions RX Formulations Services LLC is recalling 450 vials of Calcium Gluconate 10% for Injection. The affected product is a 100 mL single-dose vial intended for hospital administration only. The recall involves specific lots with expiration dates in December 2013.
The recall was initiated after a report of microbial contamination was observed when drawing the vial contents into a syringe. The product is labeled as 'Not for Dispensing' and is for hospital use only.
The recall is limited to the state of Arizona. Healthcare facilities and hospitals that have received these specific lots should stop using the product and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Calcium Gluconate 10% for Injection, SDV 100 mL SDV, PF, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ, 85205.
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 450
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 7 recalled by Zions RX Formulations Services LLC dba RX Formuations Serv. 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.
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