Recalls / Class II
Class IID-0023-2018
Product
OXYtocin 30 units added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025000101
- Affected lot / code info
- Lot#: 072017S4, Exp 11/16/2017; 072117S2, Exp 11/17/2017; 072417S2, Exp 11/20/2017; 072717S5, Exp 11/23/2017; 072817S3, Exp 11/24/2017; 073117S3, Exp 11/27/2017; 080217S3, Exp 11/29/2017; 080317S3, Exp 11/30/2017; 080917S3, Exp 12/6/2017; 081117S4, Exp 12/8/2017; 081717S3, Exp 12/14/2017; 081817S1, Exp 12/15/2017; 082217S3, Exp 12/19/2017; 082317S3, 082317S5, Exp 12/20/2017; 082417S3, Exp 12/21/2017; 082517S2, Exp 12/22/2017.
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
- 24306 units
- 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-0023-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.