Recalls / Class II
Class IID-0020-2018
Product
Magnesium sulfate 10 Gm added to Lactated Ringer's 250 mL bags, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025003201
- Affected lot / code info
- Lot #: 042017S4, Exp 10/20/2017; 042517S2, 10/25/2017; 042617S3, Exp 10/26/2017; 050317S2, Exp 11/2/2017; 050517S3, Exp 11/4/2017; 051217S2, Exp 11/11/2017; 051917S1,Exp 11/18/2017; 052917S4, Exp 11/28/2017; 061317S5, Exp 12/13/2017; 061617S1, Exp 12/16/2017; 062317S1, Exp 12/23/2017; 062817S2, 12/28/2017; 062917S1, Exp 12/29/2017; 070717S1, Exp 1/6/2018; 071317S4, Exp 1/12/2018; 072017S3, Exp 1/19/2018; 072617S6, Exp 1/25/2018; 072717S3, Exp 1/26/2018; 073117S1, Exp 1/30/2018; 080317S2, Exp 2/2/2018; 080717S1, Exp 2/6/2018; 081017S3, Exp 2/9/2018; 081717S2, Exp 2/16/2018; 082417S2, 082417S5 Exp 2/23/2018;
Why it was recalled
Lack of Assurance of Sterility.
Recalling firm
- Firm
- Banner Pharmacy Services, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7300 W Detroit St, N/A, Chandler, Arizona 85226-2410
Distribution
- Quantity
- 7578 bags
- Distribution pattern
- Nationwide within the US
Timeline
- Recall initiated
- 2017-10-10
- FDA classified
- 2017-10-23
- Posted by FDA
- 2017-11-01
- Terminated
- 2018-08-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0020-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.