Recalls / Class II
Class IID-0017-2018
Product
fentaNYL citrate 1000 mcg (10 mcg/mL) 100 mL Cassette in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025011001
- Affected lot / code info
- Lot #: 041317S1, Exp 10/10/2017; 041817S1, Exp 10/15/2017; 042017S1, 10/17/2017; 042517S1, 10/22/2017; 042717S1, Exp 10/24/2017; 050217S1, Exp 10/29/2017; 050417S2, Exp 10/31/2017; 050917S1, 11/5/2017; 051117S1, 051117S4,11/7/2017; 051617S1, 11/12/2017; 051817S1, Exp 11/14/2017; 052317S1, Exp 11/19/2017; 053017S1, Exp 11/26/2017; 060617S1, Exp 12/3/2017; 060917S1, Exp 12/6/2017; 061317S1, Exp 12/10/2017; 061517S2, Exp 12/12/2017; 062017S1, Exp 12/17/2017; 062217S1, Exp 12/19/2017; 062717S1, Exp 12/24/2017; 62817S1, Exp 12/25/2017; 070417S1, Exp 12/31/2017; 070517S1, Exp 1/1/2018; 071317S1, Exp 1/7/2018; 071817S2, Exp 1/14/2018; 072017S1,Exp 1/16/2018; 72517S2, Exp 1/21/2018; 080817S1, Exp 2/4/2018; 080917S1, Exp 2/5/2018; 081617S1, Exp 2/12/2018; 081717S1, Exp 2/13/2018.
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
- 9030 cassetts
- 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-0017-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.