Recalls / Class II
Class IID-0024-2018
Product
Ropivacaine HCL (PF) 0.2% (2mg/mL) 100 mL Cassette Rx Only Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226 NDC 7025006301
- Affected lot / code info
- Lot #: 041117S2, Exp 10/11/2017; 041817S3, Exp 10/18/2017; 042517S3, 10/25/2017; 050117S2, Exp 10/3102/17; 053017S3, Exp 11/29/2017; 060117S3, Exp 12/1/2017; 060617S3, Exp 12/6/2017; 061217S1, 12/12/2017; 062017S3, Exp 12/20/2017; 062717S2, Exp 12/27/2017; 062817S3, Exp 12/28/2017; 071117S2, Exp 1/10/2018; 071817S3, Exp 1/17/2018; 072117S3, Exp 1/20/2018; 072417S3, Exp 1/23/2018; 072517S3, Exp 1/24/2018; 080217S4, Exp 2/1/2018; 081117S3, Exp 2/10/2018; 081817S2, Exp 2/17/2018; 082317S4, Exp 2/22/2018.
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
- 2173 cassettes
- 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-0024-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.