Zions RX Formulations Recalls Potassium Phosphates Vials Due to Sterility Concerns
Zions RX Formulations is recalling 95 vials of Potassium Phosphates due to a lack of assurance of sterility caused by poor aseptic practices.
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 and involves a lack of assurance of sterility in injectable products, which poses a significant risk of serious injury or death from infection, meeting the criteria for a Severe rating.
Plain-English summary
Zions RX Formulations Services LLC dba RX Formuations Serv. is recalling 95 vials of Potassium Phosphates 4.4mEq/3mM/mL. The product is labeled "Not for Dispensing, For Hospital Administration Only" and is an Rx formulation. The recall is limited to distribution in Arizona (AZ).
The recall was initiated due to a lack of assurance of sterility. The firm expanded the recall to other injectable products after poor aseptic practices were observed at the facility. The specific lots involved are 117467@9 (expiration 12/12/2013), 117857@2 (expiration 12/15/2013), and 117740@4 (expiration 12/13/2013).
This is an FDA Class II recall. The source text does not report any specific illnesses or injuries associated with this recall. Healthcare facilities and consumers should stop using the affected vials and contact the recalling firm for further instructions.
The recalled product
- Product
- Potassium Phosphates 4.4mEq/3mM/mL Vials, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
- Category
- Drug — Injectable
- Affected units
- 95
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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