Recalls / Class II
Class IID-0018-2018
Product
fentanyl citrate (PF) 1100 mcg (20 mcg/mL) 55 mL syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025011001
- Affected lot / code info
- Lot # :051717S1, Exp 11/13/2017; 052417S1, Exp 11/20/2017; 062117S1, Exp 12/18/2017; 071217S1, Exp. 1/8/2017; 071917S1, Exp 1/15/2018; 072617S1, Exp 1/22/2018; 081017S1, Exp 2/6/2018
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
- N/A
- 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-0018-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.