Why it was recalled
Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.
Product description
Magnesium Sulfate 10gm in 250mL Lactated Ringers Bags, Not For Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
Lot numbers, UPCs & expiration codes
Lot #: 117037@3 Expiration Date: 12/13/2013 Lot #: 117899@1 Expiration Date: 01/03/2014 Lot #: 118289@7 Expiration Date: 01/09/2014 Lot #: 118078@56 Expiration Date: 01/03/2014 Lot #:118394@29 Expiration Date: 01/09/2014 Lot #: 118338@10 Expiration Date: 01/09/2014 Lot #: 118056@46 Expiration Date: 01/02/2014
Where it was sold
AZ
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1214-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 12, 2013
- FDA report date
- Apr 16, 2014
- Quantity
- 861 Bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zions RX Formulations Services LLC dba RX Formuations Serv.
Original FDA data
Every field from FDA enforcement report D-1214-2014, exactly as published.
Show all FDA fields
- City
- Mesa
- State
- AZ
- Status
- Terminated
- Country
- United States
- Event ID
- 67080
- Address
- 5949 E University Dr
- Code information
- Lot #: 117037@3 Expiration Date: 12/13/2013 Lot #: 117899@1 Expiration Date: 01/03/2014 Lot #: 118289@7 Expiration Date: 01/09/2014 Lot #: 118078@56 Expiration Date: 01/03/2014 Lot #:118394@29 Expiration Date: 01/09/2014 Lot #: 118338@10 Expiration Date: 01/09/2014 Lot #: 118056@46 Expiration Date: 01/02/2014
- Postal code
- 85205-7435
- Report date
- Apr 16, 2014
- Product type
- Drugs
- Recall number
- D-1214-2014
- Classification
- Class II
- Recalling firm
- Zions RX Formulations Services LLC dba RX Formuations Serv.
- Product quantity
- 861 Bags
- Termination date
- May 1, 2014
- Reason for recall
- Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Magnesium Sulfate 10gm in 250mL Lactated Ringers Bags, Not For Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
- Distribution pattern
- AZ
- Recall initiation date
- Dec 12, 2013
- Initial firm notification
- Center classification date
- Apr 7, 2014