The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1214-2014·Announced 2014-04-16

Zions RX Formulations Recalls Magnesium Sulfate Bags Due to Sterility Concerns

Zions RX Formulations is recalling 861 bags of Magnesium Sulfate in Lactated Ringers due to poor aseptic practices that compromise sterility assurance.

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 FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe (4). While no injuries are explicitly reported, the lack of sterility assurance in injectable drugs poses a significant risk of serious harm, aligning with the Severe criteria for high-risk medical products.

Plain-English summary

Zions RX Formulations Services LLC is recalling 861 bags of Magnesium Sulfate 10gm in 250mL Lactated Ringers. The product is labeled 'Not For Dispensing, For Hospital Administration Only' and was distributed in Arizona. The recall was initiated because the firm expanded its recall to other injectable products due to a lack of assurance of sterility resulting from poor aseptic practices observed at the facility.

The affected lots include 117037@3, 117899@1, 118289@7, 118078@56, 118394@29, 118338@10, and 118056@46, with expiration dates ranging from December 2013 to January 2014. The FDA has classified this as a Class II recall. No specific illnesses or injuries are reported in the source text, but the hazard involves the potential administration of non-sterile injectable medication.

The recalled product

Product
Magnesium Sulfate 10gm in 250mL Lactated Ringers Bags, Not For Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
Manufacturer
Zions RX Formulations Services LLC dba RX Formuations Serv.
Category
Drug — Injectable Medication
Hazard
Affected units
861

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.

See all 7 products in this recall →

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