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Zions RX Formulations Services LLC dba RX Formuations Serv.

Complete recall history across all FDA and CPSC categories — 7 total recalls

Zions RX Formulations Services LLC dba RX Formuations Serv. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (7)

FDA drug safety enforcement actions by Zions RX Formulations Services LLC dba RX Formuations Serv.

Date Product Reason Class
Dec 12, 2013 Sodium Bicarbonate 8.4%, a) 10 mL, b) 20 mL, and c) 22 mL units, Not for Disp... Lack of Assurance of Sterility: The firm expanded the recall to other injecta... Class II
Dec 12, 2013 Oxytocin 30 Units in 500mL Sodium Chloride 0.9% Bags, Not for Dispensing, For... Lack of Assurance of Sterility: The firm expanded the recall to other injecta... Class II
Dec 12, 2013 Calcium Gluconate 10% for Injection, SDV 100 mL SDV, PF, Not for Dispensing, ... Non-Sterility: RX Formulation initiated this recall due to a report of microb... Class I
Dec 12, 2013 Vitamin B-12 injections, a) 1 mL and b) 30 mL units, Not for Dispensing, For ... Lack of Assurance of Sterility: The firm expanded the recall to other injecta... Class II
Dec 12, 2013 Magnesium Sulfate 10gm in 250mL Lactated Ringers Bags, Not For Dispensing, Fo... Lack of Assurance of Sterility: The firm expanded the recall to other injecta... Class II
Dec 12, 2013 Potassium Phosphates 4.4mEq/3mM/mL Vials, Not for Dispensing, For Hospital Ad... Lack of Assurance of Sterility: The firm expanded the recall to other injecta... Class II
Dec 12, 2013 Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration... Lack of Assurance of Sterility: The firm expanded the recall to other injecta... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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