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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- 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.
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